1 NO. 90-CI-6033 JEFFERSON CIRCUIT COURT DIVISION ONE (1) 2 3 JOYCE FENTRESS, ET AL. PLAINTIFFS 4 5 VS. DEPOSITION FOR PLAINTIFFS 6 7 SHEA COMMUNICATIONS, ET AL. DEFENDANTS 8 * * * * * * * * * * 9 10 DEPONENT: LESLIE M. CHIPLIS 11 DATE: SEPTEMBER 24, 1993 12 13 * * * * * * * * * * 14 15 16 REPORTER: KATHY NOLD 17 18 KENTUCKIANA REPORTERS SUITE 260 19 730 WEST MAIN STREET LOUISVILLE, KENTUCKY 40202 20 (502) 589-2273 Page 1 1 * * * * * * * * * * 2 3 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF INDIANA 4 INDIANAPOLIS DIVISION 5 IN RE ELI LILLY AND COMPANY ) Prozac Products Liability ) MDL Docket No. 907 6 Litigation ) 7 * * * * * * * * * * 8 NO. 91-02496-A 9 JACKIE LYNN BIFFLE, ET AL ) IN THE DISTRICT ) COURT OF 10 V. ) DALLAS COUNTY, TEXAS ) 11 ELI LILLY & COMPANY AND ) 14TH JUDICIAL DISTA PRODUCTS COMPANY ) DISTRICT 12 * * * * * * * * * * 13 NO. 92-14775-E 14 RICHARD HAROLD CROSSETT, JR., ) IN THE 15 CHAD H. CROSSETT, AMY MICHELLE ) DISTRICT CROSSETT AND KRISTEN ANN CROSSETT, ) COURT OF 16 INDIVIDUALLY AND AS SURVIVORS OF ) AND ON BEHALF OF THE ESTATE OF ) 17 JOCQUETTA ANN CROSSETT, DECEASED ) ) 18 V. ) DALLAS COUNTY, ) TEXAS 19 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, TEXAS ) 20 PSYCHIATRIC COMPANY, INC. ) D/B/A/ HCA WILLOW PARK ) 101ST JUDICIAL 21 HOSPITAL, JAMES K. WITSCHY, M.D., ) DISTRICT AND DOUG BELLAMY, ED.D. ) Page 2 1 * * * * * * * * * * 2 NO. A-921,405-C 3 MARIA GUADALUPE REVES ) IN THE 4 INDIVIDUALLY AND AS NEXT ) DISTRICT COURT FRIEND OF GRANT JULIAN REVES ) OF 5 A MINOR CHILD, AND ON BEHALF ) OF THE ESTATE OF CHRISTIAN ) 6 MARIE REVES, DECEASED ) ) ORANGE COUNTY, 7 V. ) TEXAS ) 8 ELI LILLY & COMPANY, DISTA ) PRODUCTS COMPANY, RAVIKUMAR ) 9 KANNEGANTI, M.D., HOSPITAL ) CORPORATION OF AMERICA, A ) 10 TENNESSEE CORPORATION, HEALTH ) SERVICES ACQUISITION CORP., ) 11 A DELAWARE CORPORATION, ) HCA PSYCHIATRIC COMPANY, A ) 12 DELAWARE CORPORATION, TEXAS ) PSYCHIATRIC CO., INC.. A/K/A ) 13 AND/OR D/B/A HCA BEAUMONT ) NEUROLOGICAL HOSPITAL, AND HCA ) 14 HEALTH SERVICES OF TEXAS, INC. ) 128TH JUDICIAL A/K/A AND/OR BEAUMONT ) DISTRICT 15 NEUROLOGICAL HOSPITAL ) 16 * * * * * * * * * * Page 3 1 IN THE UNITED STATES DISTRICT COURT 2 FOR THE WESTERN DISTRICT OF TEXAS SAN ANTONIO DIVISION 3 ELIZABETH T. SANCHEZ, ) 4 INDIVIDUALLY AND AS THE ) SURVIVING SPOUSE, MARGARET R. ) 5 SANCHEZ, INDIVIDUALLY AND NEXT ) OF FRIEND OF DEBRA JEAN ) 6 SANCHEZ, VERONICA MARIE ) SANCHEZ, EDWARDO ESTEBAN ) 7 SANCHEZ, AND MICHAEL ANTHONY ) SANCHEZ, CHILDREN; AND ALL ON ) 8 BEHALF OF THE ESTATE OF ) EDWARDO SANCHEZ ) 9 ) V. ) CIVIL ACTION NO. 10 ) SA93CA367 ELI LILLY AND COMPANY AND ) 11 DISTA PRODUCTS COMPANY ) 12 * * * * * * * * * * 13 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS 14 HOUSTON DIVISION 15 MARIA SANCHEZ, INDIVIDUALLY ) AND AS NEXT FRIEND OF DEBORAH ) 16 SANCHEZ, VERONICA SANCHEZ, ) EDDIE SANCHEZ, AND MICHAEL ) 17 SANCHEZ, AND ON BEHALF OF THE ) ESTATE OF EDUARDO SANCHEZ ) 18 ) V. ) CIVIL ACTION NO. 19 ) H-93-1469 ELI LILLY AND COMPANY AND ) 20 DISTA PRODUCTS COMPANY, A ) DIVISION OF ELI LILLY AND ) 21 COMPANY ) Page 4 1 * * * * * * * * * * 2 STATE OF NEW YORK 3 SUPREME COURT COUNTY OF JEFFERSON 4 _____________________________________________ 5 STEPHANIE CAPONE, AS EXECUTOR OF THE ESTATE OF JOSEPH J. CAPONE, JR., AND 6 STEPHANIE CAPONE, INDIVIDUALL, NOTICE TO TAKE 7 PLAINTIFF, DEPOSITION UPON ORAL EXAMINATION 8 VS. INDEX NO. 93-251 9 ELI LILLY AND COMPANY, DISTA PRODUCTS 10 COMPANY, A DIVISION OF ELI LILLY AND COMPANY, FLOYD BAJJALY, M.D, 11 DEFENDANTS. 12 _____________________________________________ 13 * * * * * * * * * * 14 SUPREME COURT OF TEH STATE OF NEW YORK COUNTY OF ORANGE 15 --------------------------------------X BRUCE R. MALEN AS EXECUTOR OF THE : INDEX NO. 16 ESTATE OF BARBARA E. MALEN, AND OF : 4119/92 BRUCE R. MALEN, INDIVIDUALLY, : 17 : HON. PETER PLAINTIFF : PATSALOS, 18 : J.S.C. -against- : 19 : ELI LILLY & COMPANY, DISTA PRODUCTS : 20 COMPANY, A DIVISION OF ELI LILLY & : COMPANY, BARRY SINGER AND UNITED : 21 HOSPITAL, : : 22 DEFENDANTS. : --------------------------------------X 23 * * * * * * * * * * Page 5 1 ---------------------------------X 2 VALARIE J. FRIEDMAN AND DAVID : SUPERIOR COURT FRIEDMAN, HER HUSBAND, : OF NEW JERSEY 3 : LAW DIVISION: PLAINTIFF, : MIDDLESEX COUNTY 4 : DOCKET NO. : L-3191-91 5 VS. : : 6 ELI LILLY & COMPANY; DISTA : PRODUCTS INC, A DIVISION OF : 7 ELI LILLY & COMPANY; LISS : PHARMACY; MADISON PHARMACY AND : 8 JOHN DOES NOS. 1-25 (UNKNOWN : ENTITIES), : 9 : DEFENDANTS. : 10 ---------------------------------X 11 * * * * * * * * * * 12 SUPREME COURT OF THE STAET OF NEW YORK COUNTY OF SUFFOLK 13 -------------------------------------x 14 RHOMDA L. HALA and JOSEPH L. HALA, : 15 Plaintiffs, : Index No. 14869/90 16 - against - : 17 ELI LILLY & COMPANY and DISTA : PRODUCTS COMPANY, a DIVISION OF 18 ELI LILLY & COMPANY : 19 Defendants. : -------------------------------------x 20 21 * * * * * * * * * * Page 6 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 PATRICIA BRACH, ) ) 4 Plaintiff ) ) 5 v. )No. 92 L 13369 ) 6 ELI LILLY AND COMPANY, a foreign ) corporation; ALAN N. MILLER, M.D., ) 7 WILLIAM BRUINSMA, Psy.D., and ) CONDELL MEMORIAL HOSPITAL, ) 8 ) Defendants. ) 9 * * * * * * * * * * 10 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 11 COUNTY DEPARTMENT - LAW DIVISION 12 RENATO DI SILVESTRO, Individually ) and as Special Administrator of ) 13 the Estate of JOHN DI SILVESTRO, ) Deceased, ) 14 ) Plaintiff, ) 15 ) v. ) No. 91 L 7881 16 ) ROBERT L. NELSON, et al., ) 17 ) Defendants, ) 18 ) GEORGE MELNICK, M.D. and PETER ) 19 FINK, M.D. ) ) 20 Respondents in Discovery.) 21 * * * * * * * * * * Page 7 1 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 2 COUNTY DEPARTMENT, LAW DIVISION 3 JOAN M. GRYER, ) ) 4 Plaintiff, ) ) 5 v. ) No. 92 L 7387 ) 6 ELI LILLY AND COMPANY, et al., ) ) 7 Defendants. ) 8 * * * * * * * * * * 9 IN THE CIRCUIT COURT OF COOK COUNTY, ILLINOIS 10 COUNTY DEPARTMENT, LAW DIVISION 11 JENNIFER HAMMERLI, as Plenary ) Guardian of the Estate of RAY B. ) 12 HAMMERLI, a disabled person, ) ) 13 Plaintiff, ) ) 14 v. ) No. 92 L 2365 ) 15 ELI LILLY AND COMPANY, THE ) UPJOHN COMPANY, DICKIE KAY, M.D., ) 16 (former Respondent in Discovery), ) and RICHARD CZECHOWICZ (former ) 17 Respondent in Discovery), ) ) 18 Defendants. ) 19 * * * * * * * * * * Page 8 1 IN THE CIRCUIT COURT OF THE SIXTH JUDICIAL CIRCUIT 2 CHAMPAIGN COUNTY, ILLINOIS 3 LINDA GARDNER, Individually and ) as Special Administrator of ) 4 the Estate of SHANE GARDNER, ) deceased, ) 5 ) Plaintiff, ) 6 ) v. ) No. 91 L 1066 7 ) ELI LILLY AND COMPANY, a foreign ) 8 corporation, ) ) 9 Defendant. ) 10 * * * * * * * * * * 11 IN THE NINETEENTH JUDICIAL CIRCUIT COURT 12 LAKE COUNTY, ILLINOIS 13 JAMES E. SHEPPARD, Special ) Administrator of the Estate of ) 14 KENNETH K. SHEPPARD, Deceased, ) ) 15 Plaintiff ) ) 16 v. ) No. 93 L 124 ) 17 GOOD SHEPHERD HOSPITAL, a ) corporation, DR. STEWART SEGAL, ) 18 DR. SANFORD SHERMAN, DR. BRUCE ) CARLSON, DR. R. BERGLUND, and ELI ) 19 LILLY & COMPANY, a corporation, ) ) 20 Defendants. ) 21 * * * * * * * * * * Page 9 1 SUPERIOR COURT OF THE STATE OF CALIFORNIA 2 FOR THE COUNTY OF LOS ANGELES 3 DR. MARIUS SAINES, etc., et al., ) Case No: 4 ) SC 008331 Plaintiffs, ) 5 ) vs. ) 6 ) ELI LILLY & COMPANY, a corporation; ) 7 DISTA PRODUCTS COMPANY, a division ) of Eli Lilly & Company; and DOBS 1- ) 8 100, inclusive, ) ) 9 Defendants. ) ____________________________________) 10 11 * * * * * * * * * * Page 10 1 THE DEPOSITION OF LESLIE M. CHIPLIS, TAKEN 2 AT THE OFFICE OF BAKER & DANIELS, 300 NORTH 3 MERIDIAN STREET, SUITE 2700, INDIANAPOLIS, 4 INDIANA 46204, ON SEPTEMBER 24, 1993; SAID 5 DEPOSITION TAKEN PURSUANT TO NOTICE IN ACCORDANCE 6 WITH THE RULES OF CIVIL PROCEDURE. 7 * * * * * * * * * * 8 A P P E A R A N C E S 9 10 NANCY ZETTLER COUNSEL FOR GROUP A PLAINTIFFS 11 LEONARD M. RING AND ASSOCIATES, P.C. 111 WEST WASHINGTON AVENUE, SUITE 1333 12 CHICAGO, ILLINOIS 60602 13 LAWRENCE J. MYERS COUNSEL FOR ELI LILLY AND COMPANY 14 FREEMAN & HAWKINS 4000 ONE PEACHTREE CENTER 15 303 PEACHTREE STREET, N.E. ATLANTA, GEORGIA 30308-3243 16 CURTIS G. OLTMAN 17 ELI LILLY AND COMPANY LILLY CORPORATE CENTER 18 INDIANAPOLIS, INDIANA 46285 19 DALE A. DIAMOND COUNSEL FOR GOOD SHEPHERD HOSPITAL 20 333 WEST WACKER DRIVE, SUITE 1200 CHICAGO, ILLINOIS 60606 Page 11 1 WILLIAM A. ROGERS 2 COUNSEL FOR DEFENDANTS CZECHOWICZ, FINK, BRUINSMA CLAUSEN MILLER GORMAN CAFFREY & WITOUS 3 10 SOUTH LASALLE CHICAGO, ILLINOIS 60603 4 PAUL J. CLEMENTI 5 COUNSEL FOR DR. DICKIE KAY HINSHAW & CULBERTSON 6 222 NORTH LA SALLE STREET, SUITE 300 CHICAGO, ILLINOIS 60601-1081 7 KATHERINE L. LAWS 8 COUNSEL FOR DRS. WITSCHY AND KANNEGANTI BAILEY AND WILLIAMS 9 3500 NCNB PLAZA 901 MAIN STREET 10 DALLAS, TEXAS 75202-3714 11 JOHN F. PRESCOTT, JR. COUNSEL FOR ST. ELIZABETH'S HOSPITAL 12 ONE AMERICAN SQUARE INDIANAPOLIS, INDIANA 46282 Page 12 1 I N D E X 2 3 DEPOSITION OF LESLIE M. CHIPLIS 4 5 DIRECT EXAMINATION BY MS. ZETTLER 14 6 CERTIFICATE 156 7 ERRATA 157 8 9 EXHIBITS 10 PLAINTIFFS' EXHIBIT NO. 1 35 11 PLAINTIFFS' EXHIBIT NO. 2 55 12 PLAINTIFF'S EXHIBIT NO. 3 67 13 PLAINTIFFS' EXHIBIT NO. 4 72 14 PLAINTIFFS' EXHIBIT NO. 5 79 15 PLAINTIFFS' EXHIBIT NO. 6 86 16 PLAINTIFFS' EXHIBIT NO. 7 87 17 PLAINTIFFS' EXHIBITS NOS. 8, 9 and 10 107 18 19 Page 13 1 COMES LESLIE M. CHIPLIS, CALLED BY THE 2 PLAINTIFF, AND AFTER FIRST BEING DULY SWORN, WAS 3 DEPOSED AND TESTIFIED AS FOLLOWS: 4 DIRECT EXAMINATION 5 BY MS. ZETTLER: 6 MS. ZETTLER: Let the record reflect 7 that this is a discovery deposition of Leslie 8 Chiplis taken pursuant to notice in the Fentress 9 versus Shea case. 10 Q. Have you ever given a 11 deposition before, Ms. Chiplis? 12 A. No. 13 Q. Let me give you some ground 14 rules just to make it easier, mostly on Kathy 15 here. First of all, you have to answer out loud, 16 you can't shake your head or go uh-huh, and we'll 17 remind you, it's kind of human nature to say 18 uh-huh or shake your head. Is that clear? 19 A. Yes. 20 Q. If you have any questions or 21 you don't understand my question or don't hear it 22 for some reason, please let me know and I will 23 rephrase it until you can understand and answer 24 it. If you answer the question as asked, we're Page 14 1 going to assume you understood it as asked, is 2 that fair? 3 A. That's fair. 4 Q. Anytime you want to take a 5 break, let us know and we'll take a break, or if 6 you want to talk to your lawyers for any reason 7 whatsoever. And also, if you could try to let me 8 finish my question before you start your answer, 9 again this isn't like a normal conversation, you 10 can't really talk over each other because Kathy 11 can't take everything down. Okay? 12 A. Okay. 13 Q. Please state your full name, 14 please. 15 A. Margaret Leslie Chiplis. 16 Q. What's your social security 17 number? 18 A. XXXXXXXXXX. 19 Q. And your date of birth? 20 A. June 10, 1943. 21 Q. And your current address? 22 A. XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX 23 XXXXXXX. 24 Q. Do you have any current plans Page 15 1 to move? 2 A. No. 3 Q. Why don't you give us an idea 4 of your educational background after high school. 5 A. I went to LPN school which is a 6 one year program. I then went to the IU School 7 of Nursing and got my bachelors degree, I then 8 continued and got my masters degree in nursing 9 administration and then I went to IU Law School 10 and finished that in I think '89. 11 Q. How fun for you. 12 A. I don't want to ever see the 13 inside of a classroom again. 14 Q. When did you get your BS in 15 Nursing? 16 A. I believe it was '79, I 17 finished completely then. 18 Q. How about your masters? 19 A. Early '80s, '83, '84, something 20 like that. 21 Q. And did you take and pass the 22 bar? 23 A. Yes. 24 Q. Are you practicing law now? Page 16 1 A. No, not on any kind of regular 2 full-time basis like that. 3 Q. When did you take the bar? 4 A. '89. 5 Q. Any other graduate course work 6 that you have done? 7 A. No. 8 Q. Why don't we talk about your 9 employment now past high school. Other than odd 10 part-time jobs, you know, like waitressing, 11 things like that, can you give me an idea of what 12 types of work you did while you were in college? 13 A. Well, when I was an LPN, I 14 didn't do any other job and then when I was 15 getting my R.N. or my bachelors degree in nursing 16 that led to my R.N., I did nursing as an LPN. 17 Q. Where did you do nursing as an 18 LPN? 19 A. I worked with an agency and 20 whenever they would need me on the weekends or 21 anything like that, I would just kind of 22 freelance and go to that particular hospital or 23 do private duty. 24 Q. Like temporary type thing? Page 17 1 A. Yes. 2 Q. Have you ever worked as an 3 R.N.? 4 A. Oh, yes. 5 Q. Where have you worked as an 6 R.N.? 7 A. I became a full-time registered 8 nurse at IU Hospital in '79 and worked there 9 full-time until '89 when I came to Lilly. 10 Q. And what department were you in 11 at IU Hospital? 12 A. I'm sorry, would you say that 13 again? 14 Q. You worked at IU as an R.N. 15 A. Yes. 16 Q. Did you work in a particular 17 department? 18 A. I worked in actually several, I 19 worked in the renal department in dialysis, I 20 worked on a renal diabetic floor, I worked in the 21 endocrinology or diabetes area the last several 22 years I was at IU. 23 Q. Have you ever worked on, prior 24 to being at Lilly, did you ever work on a Page 18 1 clinical trial, drug clinical trial? 2 A. Yes. 3 Q. For what company? 4 A. I worked at IU and I didn't 5 work for a pharmaceutical company at all but the 6 physician I worked with did clinical trials for 7 various pharmaceutical companies in the area of 8 diabetes, that was the only area. 9 Q. I'm sorry, I didn't mean to cut 10 you off. So if he was participating in a trial, 11 you would assist him in some cases? 12 A. Yes. 13 Q. Were any of those clinical 14 trials related to antidepressants? 15 A. No. 16 Q. Did any of your 17 responsibilities as an R.N. at IU involve 18 psychiatric patients? 19 A. No. 20 Q. I think you said you began 21 working at Lilly in '89. Was that before or 22 after you got your J.D.? 23 A. I took the bar in July of '89 24 and I came to Lilly in June of '89 so it kind of Page 19 1 overlapped. 2 Q. Okay. And have you worked 3 continuously for Lilly since then? 4 A. Yes. 5 Q. What position did you start at 6 Lilly with? 7 A. I started in the drug 8 epidemiology unit. 9 Q. Were you a clinical research 10 administrator in that unit? 11 A. Yes, I would say that, yes. 12 Q. And how long were you a CRA in 13 the DEU? 14 A. I worked there until January of 15 1991. 16 Q. And then what did you do? 17 A. I went to the quality assurance 18 department. 19 Q. Okay. Have you changed 20 positions since then? 21 A. No. 22 Q. So you're still in quality 23 assurance? 24 A. That's correct. Page 20 1 Q. How is it that you found out 2 about the job at Lilly in the DEU? 3 A. You mean when I applied there 4 or what? 5 Q. Right, did you apply or were 6 you recruited in? 7 A. No, I applied at Lilly for any 8 position, I did not apply specifically for the 9 DEU. 10 Q. Who did you interview with for 11 the position, the first position? 12 A. I don't recall, I couldn't tell 13 you. 14 Q. And then I take it you got the 15 job, right? 16 A. Yes. 17 Q. Can you tell me what -- 18 generally what your responsibilities as a CRA in 19 the DEU were? 20 A. I took information and filled 21 out -- took that information and completed the 22 1639 forms, and that was my responsibility. 23 Q. Were those responsibilities the 24 same the entire time you were in the DEU? Page 21 1 A. Yes. 2 Q. When you say took information, 3 what do you mean? 4 A. Anytime Lilly had knowledge of 5 an adverse event on any drug that we marketed, we 6 reported that information to the FDA. 7 Q. Okay. But who did you take the 8 information from? 9 A. It came to me from a variety of 10 sources, it could be by the telephone, it could 11 be by letter, it could be basically any way you 12 could communicate in today's world that we got 13 information, then we reported it. 14 Q. But what people would 15 communicate these adverse events to you? 16 A. It could be a patient, it could 17 be a physician, a nurse, another Lilly employee, 18 it could be any person who would contact us. 19 Q. What's the most unusual source 20 that you can remember where you got information 21 on an adverse event? 22 A. I guess the one I remember is 23 my mother who took an antibiotic and had an 24 allergic reaction and I reported that, so I guess Page 22 1 that is unusual. 2 Q. What's the most unusual source 3 that you think of where you reported an adverse 4 event on Fluoxetine? 5 A. Gosh, I can't remember, it was 6 a lot, I just remember getting a lot of phone 7 calls and letters and those were the two main 8 ways but nothing that really stands out in my 9 head. 10 Q. Okay. Were there different 11 procedures that you were to follow depending on 12 the means by which you got an adverse event 13 report, in other words, were you supposed to 14 follow one guideline or one policy procedure for 15 reporting telephone reports and another for 16 written reports? 17 A. No. 18 Q. Tell me generally, let me start 19 out generally about the procedure that you would 20 go to once you received your report, I mean what 21 you would go through once you received your 22 report of an adverse event? 23 MR. MYERS: Any event for any product? 24 MS. ZETTLER: If there's a difference Page 23 1 between the way you reported Fluoxetine adverse 2 events as opposed to other drugs, then -- other 3 products, then I would like to know that, but let 4 me talk about it generally first. 5 MR. MYERS: Go ahead. 6 A. I would take the information no 7 matter what the media it was given to me on, and 8 I would read it and I would put the exact 9 information on the working form, a 1639 working 10 form and then I would keep that piece of 11 information I took, I call it a source document 12 or the original document, and I kept it with the 13 working form and then it would go to a research 14 physician for review, he would review it, change 15 it if necessary, sign it, it would come back to 16 our department, it would be entered into a 17 computer and then it goes to the FDA. 18 Q. Okay. Let me be sure I have 19 all these steps down right. You would review the 20 information that came in? 21 A. Would you say that again? 22 Q. You would review the 23 information that came in? 24 A. I didn't. Page 24 1 Q. Who would? 2 A. I'm sorry, I think I jumped 3 ahead. When it came to me I read it and entered 4 it, the review actually was done by the 5 physician, the final review. 6 Q. Okay. I'm talking about when 7 it originally comes in. 8 A. I'm sorry, Nancy. 9 Q. That's okay. Part of it -- 10 trust me, it's my fault, I haven't worked there 11 so I don't understand how it works. So would you 12 actually take -- say somebody called in to report 13 an adverse event, would you actually take that 14 phone call or would somebody else? 15 A. No, I would take the phone 16 call. 17 Q. OKay, and then you would just 18 make notes or was there a form you had to use 19 when you took a phone call? 20 A. I used a form. 21 Q. Was that different than the 22 working 1639? 23 A. No. 24 Q. So you would record whatever Page 25 1 you were told on the phone on the working 1639? 2 A. Yes. 3 Q. And when you say you would 4 record the exact info on the working form, you 5 mean the working form, you mean the narrative? 6 A. Uh-huh. 7 MR. MYERS: Yes. 8 A. Yes, I'm sorry. 9 Q. And after you filled out and 10 then you would get as much information as 11 possible, obviously from the person who was 12 reporting it as far as demographics and things of 13 that nature, right? 14 A. Yes. 15 Q. And all of that information 16 would be transferred on the working 1639 to the 17 clinical research physician for review? 18 A. Yes. 19 Q. Who would -- when it came back 20 to you after the CRP reviewed and signed the 21 working 1639, who would actually enter it into 22 the computer then? You don't have to give me an 23 exact name. 24 A. Just one of the technicians or Page 26 1 somebody. 2 Q. Somebody in data entry? 3 A. Yes. 4 Q. Would you review it then again 5 after it was entered into the computer? 6 A. Yes. 7 Q. And then when you say after 8 it's entered into the computer, it's sent to the 9 FDA, what do you mean by that? 10 A. I mean a copy is printed and 11 it's reported according to the guidelines of the 12 regulations. 13 Q. Okay. So a computer copy of 14 the 1639 was printed to send to the FDA? 15 A. Yes. 16 Q. I take it you know the 17 difference between a spontaneous adverse event 18 report and a clinical trial adverse event report? 19 A. Yes. 20 Q. Did you work on both types of 21 reports, reports that came in through the 22 clinical trials and spontaneous reports? 23 A. Yes. 24 Q. Was the procedure that you went Page 27 1 through any different with regards to either 2 type? 3 A. No. 4 Q. When you say that the adverse 5 events were reported to the FDA, were there 6 different ways that the adverse events were 7 reported to the FDA depending on the type of 8 adverse event? 9 MR. MYERS: What do you mean by ways? 10 Q. Well, we know that at least in 11 some cases 1639s were filled out and sent to the 12 FDA, correct? 13 A. Yes. 14 Q. Were all adverse events 15 reported to the FDA for 1639s? 16 A. I have to say I don't -- I 17 think the annual reports, and again this is just 18 a vague memory, but I think because of the volume 19 of paper, annual reports on some compounds went 20 in tabular form -- I don't think -- and again I'm 21 not absolutely sure that every single one went on 22 that exact 1639, on an annual basis or an annual 23 report. 24 Q. Okay. So let me make sure I Page 28 1 understand it. 2 A. It's hard. 3 Q. I know. Say you got an adverse 4 event that was relatively innocuous, like let's 5 say a minor rash or something along those lines. 6 A. Right. 7 Q. Would a 1639 be filled out and 8 sent to the FDA in that instance? 9 A. Eventually it is reported but -- 10 Q. By a 1639? 11 A. I don't know that, Nancy. 12 Q. So it could be a matter of in a 13 quarterly or yearly safety review it would be 14 included but you may not send an actual 1639? 15 A. Right. 16 Q. Eventually everything got 17 reported though? 18 A. Definitely. 19 Q. Are you aware of a three day 20 alert report or fifteen day alert reports? 21 A. Yes. 22 Q. Tell me what a three day alert 23 report is? 24 A. Let's see, it's been about two Page 29 1 and a half years since I did those reports. 2 Those were -- I remember those mainly related to 3 clinical trials and not so much the marketed ones 4 but they had to do with usually a death that 5 could be related to the drug, and then a three 6 day we would call the FDA on the phone in 7 addition to the paper follow up. 8 Q. When you say would deal mainly 9 with clinical trials but not so much the marketed 10 ones, what do you mean by marketed ones? 11 A. Drugs where we have a license 12 or to say an okay from the FDA for general use 13 with prescriptions. 14 Q. Okay. So preapproval? 15 A. Right. 16 MR. MYERS: Post-approval. 17 MS. ZETTLER: Post-approval, thank you. 18 Q. So the three day alert reports 19 were usually phoned in at least initially to the 20 FDA? 21 A. Yes. 22 Q. When they say three day alert, 23 is it three days after the company finds out 24 about it? Page 30 1 A. Yes. 2 Q. Obviously it could happen a 3 month before but if the company doesn't find out 4 about it, how are they going to report it, right? 5 A. Yes. 6 Q. How about fifteen day alert 7 reports? 8 A. Fifteen day alerts are more 9 related to the post-marketing and again those 10 would have to meet a certain criteria defined by 11 the FDA which they define serious, and then they 12 would have to be related to the drug. 13 Q. Okay. 14 A. And unexpected. 15 Q. Serious and unexpected? 16 A. Unexpected. 17 Q. So three -- 18 A. Three criteria. 19 Q. Serious, unexpected and 20 causally related? 21 A. Possibly causally related. 22 Q. Was it part of your job as a 23 CRA to make the determination as to whether or 24 not something was -- fell into the fifteen day Page 31 1 alert category? 2 A. No. 3 Q. Who would make that decision? 4 A. The research physician. 5 Q. Would you flag those reports 6 for them if there was something you suspected 7 would be a fifteen day alert type thing, would 8 you flag that for them and make them aware of it 9 or whatever? 10 A. I don't remember flagging them 11 with any special kind of tag or anything like 12 that. 13 Q. Would you make them aware of 14 them? 15 A. If I highly suspected it, I 16 would. 17 Q. Did the clinical research 18 physicians review all working 1639 forms? 19 A. Yes. 20 Q. Okay. For instance, our minor 21 rash example that we used a little earlier, would 22 a clinical research physician review a 1639 on 23 that? 24 A. Yes, it would go through his Page 32 1 desk, yes. 2 Q. What was the criteria for 3 something to be considered serious under the FDA 4 regulation? 5 A. I believe there's like six or 6 seven and I'm not sure I can remember them all, 7 but I do know the ones I remember are death, 8 birth defect, cause cancer, hospitalization, 9 those are the ones I can remember. 10 Q. Was overdose included? 11 A. Yes, I think it was, yes. 12 Q. And how about unexpected, what 13 was the FDA definition of unexpected, if you 14 know? 15 A. As I remember, unexpected is 16 something that we do not kind of anticipate or we 17 haven't put that in our literature that this is a 18 possible side effect or possible adverse event. 19 Q. When you say your literature, 20 what do you mean? 21 A. Like the package insert or it 22 would be printed in the PDR type thing, those 23 kinds of literature. 24 Q. PDR is really just a copy of Page 33 1 the package insert, right? 2 A. Right. 3 Q. Any other literature that you 4 would use that you would refer to? 5 A. I think it's just really any 6 literature that we use, I couldn't say what all 7 those pieces of literature are, because I have 8 not worked in that department. 9 Q. Okay. How about possibly 10 causally related? 11 A. That's really a -- completely a 12 research physician's determination. 13 Q. Are you aware of any FDA 14 guidelines regarding what would be considered 15 possibly causally related? 16 A. No, I don't, I don't know of 17 any. 18 Q. Were you ever asked to make 19 that determination on an adverse event? 20 A. No, not me. 21 Q. You do have a nursing 22 background, right? 23 A. Right, but that doesn't qualify 24 me at all to make a causality determination. Page 34 1 (PLAINTIFFS' EXHIBIT NO. 1 WAS 2 MARKED FOR IDENTIFICATION AND 3 RECEIVED IN EVIDENCE.) 4 Q. If you need more time to look 5 at it, that's fine, it's up to you. 6 A. Let me ask -- 7 MR. MYERS: Let her ask the question. 8 Q. You have had a chance to look 9 at it? 10 A. Yes. 11 Q. If you feel like you need to 12 refer back to it, obviously I will point out to 13 you some places in there too, if you need more 14 time to read it more carefully, then let me know. 15 A. Okay. That's fine. 16 Q. Do you recognize this document, 17 Exhibit 1? 18 A. No. 19 Q. Okay. Let me just put in the 20 record what it is though. It's -- at the top of 21 the document it says Eli Lilly and Company Drug 22 Experience Network summary format, starting with 23 Pz 4772984 and it goes on to list what appear to 24 be various elements describing the drug Page 35 1 experience network or DEN, correct? 2 A. Uh-huh. 3 MR. MYERS: Yes. 4 A. Yes. 5 Q. Don't worry about it, it's 6 perfectly normal. From your review of this, and 7 again if you need more time, does this accurately 8 reflect the policies that you recall when you 9 worked in the DEU that report things of that 10 nature? 11 A. I'll have to take some more 12 time to read it then. 13 Q. That's fine. 14 (WITNESS READS DOCUMENT.) 15 Q. In the first paragraph, it says 16 about six lines down, studies i.e. spontaneous as 17 well as serious or significant drug experiences. 18 What's a significant drug experience? 19 A. Well, the definition in here is 20 that it would be a hazard or unusual -- I'm just 21 going to refer to the definition in here because 22 I don't really recall it by memory. 23 Q. Okay. 24 A. Now I can't find the Page 36 1 definition. 2 Q. Try page five. 3 A. Thank you. Significant, an 4 adverse event usually occurring in a clinical 5 investigation that does not meet the criteria for 6 inclusion in one of the categories above but that 7 may suggest significant hazards, 8 contraindications, side effects and precautions 9 pertinent to the safety of the drug, non-clinical 10 information suggesting a significant risk for 11 humans fall in this category and any finding of 12 mutagenicity, teratogenicity, or cardionogenicity 13 in laboratory animals is always considered 14 significant. 15 Q. Okay. Can you give me an 16 example of an adverse event that would be 17 considered significant but not serious/expected, 18 or not serious actually? 19 A. If I did that, Nancy, it would 20 just be from my -- just no knowledge, just 21 something that I would surmise in my head and 22 those decisions were really made by research 23 physicians and unless I knew a lot about a 24 product and the patient, I really couldn't -- Page 37 1 Q. But were there -- 2 A. -- give you an example. 3 Q. With regards to Fluoxetine, 4 were there adverse events that you were aware of 5 or made aware of that were considered significant 6 but not serious under the FDA criteria? 7 MR. MYERS: You mean that were reported 8 that way? 9 MS. ZETTLER: Right. 10 MR. MYERS: If she recalls any? 11 MS. ZETTLER: Right. 12 A. I don't really recall any. 13 Q. So the determination as to 14 whether something is serious/expected, 15 serious/unexpected, significant, whatever, was 16 made by the clinical research physicians and not 17 the CRA? 18 A. Yes. 19 Q. That paragraph that you just 20 read on page five under significant, it says 21 non-clinical information, what do they mean by 22 non-clinical information, if you know? 23 A. I don't know. 24 Q. Were you given any training Page 38 1 when you became CRA in the DEU? 2 A. Yes. 3 Q. Can you give me a description 4 of what kind of training you went through? 5 A. I had another person who worked 6 with me and who would review my work. That 7 person explained the form and then showed me how 8 to do it. I was given, you know, literature to 9 read and my work was monitored very closely. 10 Q. Okay. What kind of literature 11 were you given? 12 A. Oh, you know, I don't recall. 13 Q. Was it literature that was 14 specifically related to policies in the DEU? 15 A. It's possible, I don't recall. 16 Q. Do you remember if it was 17 literature that was created by Lilly or somebody 18 at Lilly? 19 A. Not necessarily. We were -- 20 had some articles written by FDA people as well, 21 so it would not be just Lilly generated articles. 22 Q. Okay. Was it a compilation of 23 different articles, things like that, or was it a 24 manual type of thing or was it individual Page 39 1 documents that were given to you? 2 A. Again, I'm sorry, I don't 3 recall. 4 Q. What's the difference between a 5 trial and an investigation? 6 MR. MYERS: Generally or as referenced 7 in this document? 8 MS. ZETTLER: As referenced in this 9 document. 10 MR. MYERS: What are you looking at? 11 MS. ZETTLER: Very first paragraph. 12 A. Okay. I know what a clinical 13 trial is but I don't know what the definition of 14 an investigation is according to this document, 15 but it says to see organization, sources of 16 report and type for definitions. Is that in 17 here? 18 Q. Was that ever differentiated to 19 you while you were a CRA, in other words did 20 anybody ever explain to you that there was a 21 difference between those two and that difference 22 might make a difference in how you reported and 23 collected information in adverse events? 24 A. Oh, here, I see the definition Page 40 1 on page two. 2 Well, a trial, yes. An 3 investigation, I don't really remember. I don't 4 remember getting a lot of reports or anything 5 from investigations as defined by here, by this 6 definition. 7 Q. What's your understanding of 8 what the definition in this document is for an 9 investigation? 10 A. It says from reports received 11 by Lilly that are serious or significant from a 12 Lilly sponsored study, the data of which are not 13 incorporated in the Lilly clinical trial data 14 base but which are not included in spontaneous 15 and trial above, it says note, routine trial and 16 investigation reports received by Lilly from a 17 Lilly sponsored clinical trial that are minor 18 other than serious or significant will be phased 19 into the DEN quarterly summary at a future date. 20 Q. So what is the difference 21 between a clinical trial and a Lilly sponsored 22 study? 23 A. Okay. I would only be guessing 24 about the investigation. Page 41 1 Q. Are you aware of studies that 2 were sponsored by Lilly that weren't considered 3 clinical trials? 4 MR. MYERS: Under these definitions? 5 A. Under these definitions? 6 Q. Under these definitions or any 7 definitions, start with these definitions. 8 A. No I'm not aware of any. 9 Q. Have you ever heard the phrase 10 Lilly sponsored study before? 11 A. Yes, I have heard that. 12 Q. In what context? 13 A. I can't tell you. All I know 14 is those words ring a bell in my ears, so I've 15 heard that before. 16 Q. Okay. And I guess earlier you 17 said you don't recognize this document? 18 A. No, I don't remember seeing 19 this specific document. That doesn't mean I 20 didn't see it because I haven't worked in this 21 department since '91, so -- 22 Q. You left the DEU in January of 23 '91? 24 A. Yes. Actually it was probably Page 42 1 December of '90 and then we had our -- I came 2 back at the first of the year and started in the 3 new department so I would have to say January of 4 '91. 5 Q. Okay. Are you familiar with 6 the DEN data base? 7 A. Yes. 8 Q. Were there any other data bases 9 at Lilly to your knowledge where adverse events 10 were stored, information on adverse events were 11 stored besides the DEN? 12 A. No. 13 Q. Was there a data base where 14 adverse events, non-serious adverse events 15 occurring in clinical trials were stored? 16 A. They would be with the clinical 17 trial data base. 18 Q. Okay. Was that also part of 19 the DEN, was that considered part of the DEN? 20 A. I'm not a computer person and 21 that system is complex, I don't know if they -- I 22 don't know how they were related or if they were. 23 Q. Did you have any decision 24 making authority to -- as to which data base a Page 43 1 particular adverse event would be entered into? 2 A. No. 3 Q. So there's the DEN data base 4 and then there's the clinical trial data base, 5 were there any other data bases that you recall? 6 A. Not that I know of. 7 Q. What types of adverse events 8 would be stored in the clinical trial data base? 9 A. Those that didn't meet the 10 serious criteria by the FDA. 11 Q. Would the unexpected criteria 12 play a role in that at all? In other words, if a 13 clinical trial adverse event was considered 14 serious but was expected, would that be placed in 15 the clinical trial data base? 16 A. From my memory, it would go in 17 the DEN data base if it was serious. 18 Q. As long as it was serious, it 19 would be placed in the DEN data base? 20 A. Uh-huh. 21 MR. MYERS: Yes. 22 A. Yes. 23 Q. That's okay. Can you give me 24 an example of a non-serious clinical trial Page 44 1 adverse event that would be placed in the 2 clinical trial data base as opposed to being 3 placed in the DEN data base? 4 A. And this would just be an 5 example, not from any specific knowledge. 6 Q. Sure. 7 A. A patient took one of our 8 clinical trial medications and had a mild 9 headache, it would be recorded on the case report 10 form and goes into the clinical trial data base 11 and is reported to the FDA with that final study 12 report for that particular clinical trial. 13 Q. Okay. Again would serious be 14 serious under the FDA regulation? 15 A. Uh-huh. 16 MR. MYERS: Yes. 17 A. Yes. 18 Q. And those criteria, the ones 19 that you recall at least were death, I believe 20 hospitalization, congenital anomaly, cancer, 21 overdose were the ones that you remembered, 22 right? 23 A. Yes. 24 MR. MYERS: May I take my break now? Page 45 1 MS. ZETTLER: Sure. 2 (A SHORT RECESS WAS TAKEN.) 3 Q. So adverse events from the 4 clinical trials that fell under those categories 5 or that category, would be put into the DEN data 6 base? 7 MR. MYERS: By that category, you mean 8 serious? 9 MS. ZETTLER: Right, the serious 10 category. 11 A. Would you repeat that one more 12 time? 13 Q. Sure. The adverse events from 14 clinical trials that fell under the serious 15 category would be placed in the DEN data base? 16 A. Yes. 17 Q. Are you aware that Lilly 18 assigned control numbers to the event reports? 19 A. Yes. 20 Q. Do you have any knowledge as to 21 how those numbers were constructed? 22 A. Yes. The first two letters 23 were the country, the next two were the year, the 24 next two numbers, and then the next two numbers Page 46 1 were the months and then I think there's eight 2 all together. The last four, I think they were 3 just kind of random, I'm not sure that there was 4 any significance to the last four numbers. 5 Q. Okay. 6 A. I'm unaware if there is. 7 Q. So you don't know whether or 8 not it was like say the three hundred 9 sixty-fourth report for that year and month? 10 A. I don't know. 11 Q. Could you look at page four of 12 that exhibit? 13 A. Yes. 14 Q. Under detailed listings page, 15 complaint number, number one complaint number, 16 if you could just read that real quick. 17 A. Okay. The first four digits 18 are the year and month the report were entered 19 into the Lilly DEN data base, and then 20 parentheses year year, month month, 8305 equals 21 May, 1983, parentheses. 22 Q. And that's consistent with what 23 you just said as far as the year and the month 24 being reported? Page 47 1 A. Yes, correct. 2 Q. Then it says the next four 3 digits are sequential. 4 A. Okay. 5 Q. Does that indicate to you 6 whether or not that was the next four digits 7 related to the number of the event as far as when 8 it came in, you know, if it's the one thousand 9 fifty-second report, things like that? 10 A. Yes, it must be, right. 11 Q. And then after that, it says 12 for each report, the first patient described is 13 assigned the letter A, do you understand what 14 they mean there? 15 A. Yes. 16 Q. What does that mean? 17 A. That means that, let's see how 18 am I going to do this, I have to use an example 19 to explain it. 20 Q. Okay. 21 A. And this really related to more 22 of the DES complaints rather than, at least from 23 my example, than any other drug, it wouldn't 24 relate to -- say, for instance, if a mother -- Page 48 1 and it could be any drug, but if a mother took a 2 drug and it affected the fetus or the baby, then 3 mother would be A and baby would be B using the 4 same number. That system was stopped at some 5 point and I can't tell you exactly when but it 6 was while I was in the DEU during those years and 7 you will not find after a certain date the A and 8 B. 9 Q. Okay. But that was stopped 10 while you were a CRA? 11 A. I said that it did and yet now 12 I'm thinking that it may have been shortly before 13 I came but I remember working with reports with 14 the A and B and without the A and B. 15 Q. Okay. So just so that I 16 understand in the situation that you gave, it 17 would be one adverse event because the mother had 18 taken the drug and it affected the baby somehow 19 and then -- 20 A. Right. 21 Q. But it would be listed as two 22 separate events, one A and one B? 23 A. Right, the same number, the 24 numbers would be identical, the distinguishing Page 49 1 part of the number would be the A-B. 2 Q. Okay. Do you recall a 3 situation where say somebody was on Fluoxetine 4 and intentionally hurt -- or hurt somebody else 5 while on Fluoxetine and the A-B categories being 6 used? 7 A. I don't remember the A-B being 8 used on that situation that you just described, 9 Nancy. 10 Q. Okay. Besides receiving and 11 documenting adverse event reports, what other 12 responsibilities did you have with regards to 13 Fluoxetine only while you were a CRA? 14 A. Well, when I was a CRA, I had 15 really little responsibility on Fluoxetine. The 16 only responsibility I had was to take -- was to 17 report the adverse events as they came to me. I 18 had no responsibility to the cluster or the 19 medical department related to Fluoxetine. 20 Q. When you say the cluster, what 21 do you mean? 22 A. That's a Lilly word meaning the 23 group of people who are assigned one particular 24 task, it's kind of a team that tries to get a Page 50 1 particular task done. 2 Q. Who was your direct supervisor 3 when you were a CRA in the DEU? 4 A. My direct supervisor was a 5 department head and I just can't recall that 6 name, my first supervisor, the department head. 7 The second one was Melissa Humbert and the 8 manager throughout that time who was over the 9 department head was Mike Noone. 10 Q. Mike Noone? 11 A. Yes. 12 Q. So there was another supervisor 13 before Melissa and you don't recall that person's 14 name? 15 A. Correct, I don't recall the 16 name. 17 Q. Do you remember if it was a man 18 or woman? 19 A. No, I don't remember that. 20 Q. Okay. How long was Melissa 21 your supervisor? 22 A. Not very long because I left -- 23 it wasn't too long after she came as department 24 head that I was transferred to another Page 51 1 department, so maybe several months, not much 2 more than that. 3 Q. Anita Fletcher, does that sound 4 familiar? 5 A. I know Anita and she was not a 6 department head. 7 Q. When you were a CRA, did you 8 work with the ELECT dictionary? 9 A. Yes. 10 Q. Can you tell us what the ELECT 11 dictionary is? 12 A. It's a book comprised of 13 medical terms which then can be mapped or would 14 be directly connected to a second medical term. 15 Q. Okay. And when you say medical 16 terms, you mean the event terms? 17 A. Event terms, right. 18 Q. While you were a CRA, was there 19 a change from the ELECT dictionary to the COSTART 20 dictionary? 21 A. I don't know that -- I don't 22 remember that occurring while I was a CRA in this 23 area. 24 Q. Are you aware that at some Page 52 1 point Lilly changed from ELECT to COSTART? 2 A. No. 3 Q. Okay. How about the Signs, 4 Symptoms And Illnesses dictionary, did you ever 5 work with that as a CRA? 6 A. I don't remember working with 7 that. 8 Q. While you were a CRA, were 9 event terms that were listed in the ELECT 10 dictionary ever changed? 11 A. I vaguely remember words being 12 changed but I couldn't recall what those words 13 were. 14 Q. Okay. Do you recall the term 15 intentional injury being changed to anything like 16 another phrase? 17 A. No, I don't recall. 18 Q. How about suicide attempt? 19 A. I don't recall it being -- I 20 don't recall whether it was or was not changed. 21 Q. How about intentional overdose? 22 A. Again, I don't recall. 23 Q. After an initial adverse event 24 report came in, would you be in charge with doing Page 53 1 follow up on that report? 2 A. Yes. 3 Q. Tell me what situations you 4 would be asked to do follow up. 5 A. If it were serious or if it was 6 even maybe not serious according to the 7 regulations, but we had -- didn't have enough 8 information or we just wanted to get more 9 information. 10 Q. Would it be a matter of an 11 adverse event being reported, let's say use 12 telephone call as an example, let's use your mom 13 as an example. 14 A. Okay. 15 Q. Say in the situation with the 16 antibiotic, she reported that she had a reaction 17 on it, would it be a matter of you on your own 18 following up with that or would you give it to 19 the CRF or CRP person and they would tell you to 20 do follow up? 21 A. On that one, I would have just 22 filled out with all the information I knew and 23 then gave it to the research physician. 24 Q. And then would it be the Page 54 1 research physicians decision whether or not to do 2 any additional follow up on that? 3 A. Yes. 4 Q. Was that pretty much the 5 procedure across the board with regards to 6 Fluoxetine? 7 A. From what I recall, yes. 8 Q. So you would get a report of an 9 adverse event, you would fill out the working 10 form the best you could and give that working 11 form to the clinical research physician? 12 A. Yes. 13 Q. And then if the clinical 14 research physician felt that more information was 15 needed or follow up was needed, he or she would 16 instruct you to then pursue that? 17 A. Yes. 18 (PLAINTIFFS' EXHIBIT NO. 2 WAS 19 MARKED FOR IDENTIFICATION AND 20 RECEIVED IN EVIDENCE.) 21 Q. Have you had a chance to review 22 Exhibit 2? 23 A. Yes. 24 Q. Okay. Page 55 1 A. At first I thought you meant 2 number two, page. 3 Q. It appears to be a collection 4 of E-mails discussing adverse event terms? 5 A. Yes. 6 Q. Let's just -- at the top of the 7 first page, it talks about the DEN number, and is 8 that what we talked about earlier, this one would 9 be in French, I believe, and reported in August 10 of '90? 11 A. Yes. 12 Q. At least according to Exhibit 13 1, the hundred and seventy-ninth report, whatever 14 time period it's encompassing. 15 A. Yes. 16 Q. And here's the letter A. 17 A. Yes. 18 Q. Does it indicate that there's a 19 B? 20 A. No. 21 Q. Okay. What's the A in this 22 situation? 23 A. I can't tell you, I don't know. 24 Q. But at least according to the Page 56 1 procedure that used to be, there would be A-B? 2 A. No. 3 Q. Okay, that's what I'm confused 4 about. 5 A. No. 6 Q. Explain the difference to me. 7 A. Okay. There would be an A but 8 that doesn't necessarily mean there would be A-B. 9 Q. Okay. So if there was like in 10 your DES, D-E-S situation, if there was an A-B, 11 it would be related to A? 12 A. But A could just be a 13 denominator for whatever. 14 A. Right. 15 MR. MYERS: A could just be A. 16 THE WITNESS: Right. 17 Q. Okay. The first one is -- 18 there's a blank and then it says DEN, the number 19 we just talked about, FR90080179A, correct? 20 A. Yes. 21 Q. What would that information 22 that's blacked out generally be, not 23 specifically, is that a patient number? 24 A. Nancy, I have no idea. Page 57 1 Q. Do you recall from just looking 2 at these generally what that would have been? 3 A. No. 4 Q. Does this control number, the 5 DEN number indicate to you whether or not this 6 was an event that occurred in a clinical trial or 7 was it a spontaneous event? 8 A. I would be guessing. 9 Q. Okay. Do you recall the 10 country code being used for spontaneous as well 11 as clinical trial adverse event reports? 12 A. I really don't remember. 13 Q. Okay. Have you ever written an 14 E-mail such as this where you have used that 15 patient's actual name? 16 A. No. I may use initials but not 17 names. 18 Q. Okay. Who is Frederique 19 Leredde? 20 A. I haven't met him and from -- 21 he must be a person in the French affiliate. 22 Q. Would he be someone such as 23 yourself, a CRA? 24 A. I don't know, I just don't Page 58 1 know. 2 Q. Under the first again, the 3 first event, it says as discussed in DEN training 4 please mark overdose as an outcome. What was DEN 5 training? 6 A. DEN training occurred when our 7 affiliates came on line with the DEN system and 8 they were trained in the DEN system. 9 Q. Okay. Were you involved in 10 that training? 11 A. No. 12 Q. Was that before you became a 13 CRA? 14 A. No. 15 Q. Was it before you went to 16 Quality Assurance? 17 A. Yes. 18 Q. Where did that training take 19 place? 20 A. In the affiliates. 21 Q. Who trained them? 22 A. I don't recall. 23 Q. Was it anybody from 24 Indianapolis that would go to the affiliates? Page 59 1 A. Yes. 2 Q. Do you remember any of the 3 people you worked with going to the affiliates to 4 train? 5 A. No, I don't remember. 6 Q. Have you ever heard of Laura 7 Fludzinski? 8 A. Yes. 9 Q. Who's Laura, what did she do or 10 does she do at Lilly? 11 A. Laura is in Erl Wood presently 12 and I don't know what her job was at Lilly while 13 I was in the DEU. 14 Q. Did she work in the DEU? 15 A. No. 16 Q. If you look at the top, there's 17 the listing, the CC list. 18 A. Yes. 19 Q. Does this list refresh your 20 recollection as to who your first immediate 21 supervisor was while you were in the DEU? 22 A. No. 23 Q. Do you remember that it was not 24 any of these people? Page 60 1 A. It was none of these. And I'm 2 beginning to kind of remember that maybe we 3 didn't have a department head when we first came 4 there, maybe Mike Noone was our manager, that 5 could very well be possible. 6 Q. And then later on a department 7 head was created? 8 A. Came in, right. 9 Q. And that would have been 10 Melissa Humbert? 11 A. I think so. 12 Q. Would you look at the last page 13 of Exhibit 2 please? 14 A. Yes. 15 Q. Under the regarding, it says 16 your patient I.D. blank and then it has the 17 control number, event terms, nausea, and 18 underneath that it says please provide us with 19 the following information regarding --- 20 MR. MYERS: Wait a minute, I think 21 we're on the wrong page. 22 A. Did you say the last page? 23 Q. Yes, 983 202. 24 A. No. Page 61 1 Q. Do you have a 983 202 in there? 2 It's the next to the last page in this one. 3 A. Okay. 4 Q. So on Pz 983 202, it says event 5 term nausea, do you see that? 6 A. Yes. 7 Q. And then under that it says 8 please provide us with the following information 9 regarding this patient, did suicidal thoughts 10 occur prior to Prozac therapy, does the patient 11 continue to have suicidal thoughts, is the 12 patient losing weight. Do you see that? 13 A. Yes. 14 Q. Why is the event term nausea 15 listed there? 16 A. I would have to see the full 17 text of the report to tell you, Nancy. 18 Q. Okay. Was there a situation 19 where you would list nausea like in this case and 20 not put suicidal thoughts or depression in there? 21 A. No. 22 Q. Is it your recollection that 23 suicidal ideation mapped to depression in the 24 ELECT dictionary? Page 62 1 A. I would have to look at the 2 dictionary. 3 Q. Do you have any specific 4 memories what event terms mapped -- what terms 5 mapped to what event terms in the ELECT 6 dictionary? 7 A. No. The dictionary is so big 8 and there are so many terms that I could not 9 remember. 10 Q. Did you have a copy of the 11 ELECT dictionary? 12 A. Yes. 13 Q. And you had it in your personal 14 files, in other words you didn't have to go to 15 some central place in your department, you had 16 your own copy? 17 A. Yes. 18 Q. Did you ever turn a copy of 19 that over to the legal department, as part of 20 your file? 21 A. Not while I was in the DEU. 22 Q. Did you turn your documents 23 over to the legal department when you left the 24 DEU, the DEU documents? Page 63 1 A. The DEU documents I left in the 2 DEU. 3 Q. How many copies of the ELECT 4 dictionary did you have? 5 MR. MYERS: Her? 6 MS. ZETTLER: Yes, personally. 7 A. I don't know, I can't imagine 8 I'd have more than one. 9 Q. Do you recall it ever being 10 revised while you were working in the DEU? 11 A. Yes. 12 Q. And if you got a new copy, a 13 revised copy of the dictionary, what would you do 14 with your old copy. 15 A. Turn it in. 16 Q. Turn it in to who? 17 A. I don't remember. 18 Q. Do you recall turning over any 19 copies of the ELECT dictionary over to the legal 20 department? 21 A. No. 22 Q. Do you remember turning Prozac 23 related documents over to the legal department on 24 a regular basis? Page 64 1 A. Not while I was in the DEU. 2 Q. Okay. 3 A. Oh, yes, my mind is thinking -- 4 actually I think some documents went to the legal 5 department, but again, Prozac wasn't my primary 6 responsibility, I would just do the reports so 7 whoever was in charge or who was in charge of 8 that particular drug had that responsibility. 9 Q. What responsibility? 10 A. If there was a need to turn 11 documents over, that person would do it. 12 Q. They would collect your 13 documents, your Prozac related documents? 14 A. Right, because they went to a 15 central file. 16 Q. Okay. When you say Prozac 17 wasn't your main responsibility, what other drugs 18 or types of drugs did you work on? 19 A. Insulin, DES, I worked with 20 some of the the OUS reports and then we all did 21 reports as they came in, in addition. 22 Q. So it wasn't a matter of all 23 antibiotic drug adverse event reports were sent 24 to you automatically, it was whoever was Page 65 1 answering the phone at the time? 2 A. Right. 3 Q. When you say you worked with 4 OUS reports, what do you mean? 5 A. Reports that came from outside 6 the United States. 7 Q. On all drugs or just on Prozac? 8 A. No, I think this was just the 9 last couple of months that I was in the DEU and 10 it was more all drugs than just Prozac. 11 Q. Are you aware that there was an 12 OUS Prozac clinical trial data collection 13 project? 14 A. No. 15 Q. Were you involved in any way 16 with collecting adverse event information that 17 had occurred previously or had been collected 18 previously in clinical trials outside the United 19 States? 20 A. No. 21 Q. Were you on the Prozac safety 22 team? 23 A. No. 24 Q. Were you familiar with the Page 66 1 Prozac safety team, have you ever heard that term 2 before? 3 A. No. 4 (PLAINTIFF'S EXHIBIT NO. 3 WAS 5 MARKED FOR IDENTIFICATION AND 6 RECEIVED IN EVIDENCE.) 7 Q. Have you had a chance to review 8 Exhibit 3? 9 A. Yes. 10 Q. Does this refresh your 11 recollection as to whether or not you were 12 involved with the Prozac safety team? 13 A. No, not really. I see that my 14 name's on it, and reading these I can kind of 15 guess what I did and that is probably read 16 through certain -- a stack of 1639s and check for 17 events for hostility or violence. But to be 18 actually involved in a safety team, I don't 19 recall. 20 Q. Okay. The exhibit is comprised 21 of two E-mails, correct? 22 A. Yes. 23 Q. And they're both dated November 24 14, 1990, correct? Page 67 1 A. Yes, and that date tells me why 2 I don't really remember much about this at all 3 and that is because I was interviewing for the 4 other department and I was gone within about a 5 month, so I don't even -- I don't remember any 6 more. 7 Q. Do you remember reviewing 1639s 8 to look for incidents of hostility/violence? 9 A. I remember looking through 10 1639s for a lot of different -- for many 11 different drugs, Nancy. But honestly, I don't 12 specifically remember looking at the Prozac ones. 13 Q. Okay. You were also listed on 14 the second page of the exhibit as being assigned 15 to aplastic anemia and neuroleptic malignant 16 syndrome, correct? 17 A. Yes. And I do remember 18 looking through those. 19 Q. The 1639s? 20 A. Yes. 21 Q. For Prozac? 22 A. I don't remember that it was 23 Prozac. Actually if I remember correctly, it was 24 maybe even a different drug but, you know, I Page 68 1 don't remember. 2 Q. Okay. How is it that you got 3 1639s, was it somebody delivered them to you and 4 said this is what you look through? 5 A. Correct. 6 Q. Do you remember who delivered 7 them to you? 8 A. No. 9 Q. What if you found a 1639 that 10 was for instance related to a neuroleptic 11 malignant syndrome, what would you do with it? 12 A. I gave them to the research 13 physician, I just put them in a pile and gave 14 them to him to review further. 15 Q. Have you ever heard of the term 16 hit? 17 A. Hit? No. 18 Q. Which research physician would 19 you give it to? 20 A. It would have been either 21 Charles Beasley, I think it was Charles Beasley 22 on the malignant syndrome. 23 Q. How about the aplastic anemia? 24 A. I don't remember. Page 69 1 Q. How about hostility/violence? 2 A. I don't remember. 3 Q. What did you do with the rest 4 of the 1639s that were not related to neuroleptic 5 malignant syndrome or aplastic anemia, what would 6 you do with those? 7 A. Since they were generated 8 through the computer, I probably put them in the 9 confidential barrel. 10 Q. Did Doctor Beasley or any of 11 the other clinical research physicians give you 12 back any 1639s saying these really aren't related 13 to neuroleptic syndrome? 14 A. I don't remember. 15 Q. What did Doctor Beasley do with 16 the 1639s that you gave him, if you know? 17 A. I don't remember, and I -- I 18 think it was Doctor Beasley, I can't absolutely 19 one hundred percent say. 20 Q. What other clinical research 21 physicians did you work with when you were in the 22 DEU? 23 A. The physicians I worked with 24 probably were more related to the insulins and Page 70 1 the DES, I wasn't really intricately involved or 2 even a lot involved with the Prozac cases. 3 Q. Just at the top of page one of 4 Exhibit 3, refresh your recollection as to 5 whether or not there was a direct supervisor 6 prior to Melissa Humbert and, if so, who that 7 was? 8 A. No, because Melissa is listed 9 here, so again, I don't see -- 10 Q. The two people listed under 11 two, Beasley, Chappell, Heiligenstein, Satterlee, 12 Street, Thompson, Wheadon, are they all clinical 13 research physicians? 14 A. Yes. 15 Q. If you could look back at 16 Exhibit 2, I believe. These different -- like 17 for instance, again on the first page under the 18 first adverse event, as discussed in DEN 19 training, please mark overdose as an outcome for 20 each event term of overdose. Is this considered 21 a template, to your knowledge, have you ever used 22 that word template? 23 A. No. 24 Q. Have you ever heard the phrase, Page 71 1 OUS messenger template? 2 A. OUS messenger, I'm familiar 3 with that but not template, no. 4 Q. What's an OUS messenger? 5 A. It's just a message from 6 outside the United States from one of our 7 affiliates on the E-mail system. 8 Q. And they called them messsenger 9 or messages? 10 A. I think they call it messenger. 11 I call it messenger, I could be incorrect. 12 Q. Were you ever told that when 13 you responded to messengers from outside the 14 United States you were to use specific language 15 in your response? 16 A. No, I don't remember being told 17 that. 18 Q. Are you familiar with the FDA 19 spontaneous reporting system? 20 A. No. 21 (PLAINTIFFS' EXHIBIT NO. 4 WAS 22 MARKED FOR IDENTIFICATION AND 23 RECEIVED IN EVIDENCE.) 24 Q. Do you recognize this document? Page 72 1 A. Yes. 2 Q. Can you tell me what it is? 3 A. Yes, it's a -- the results of 4 assays on a drug which I can't really -- it looks 5 like it would be items PU 3105. 6 Q. When you say item, what do you 7 mean? 8 A. It says item coding, that tells 9 me what that item is, although you have to have -- 10 I would have to have some kind of a code book to 11 tell me, but it's the result of an assay on one 12 of our products. 13 Q. What's an assay? 14 A. Assay is when -- and this is in 15 lay terms and I'm not a chemist, but you take a 16 pill or a vial of insulin and the chemist in the 17 lab they do things to it and then they can tell -- 18 identify it as being that particular drug. They 19 can tell the potency and different things about 20 it that chemists do. 21 Q. If you had a report of an 22 adverse event for somebody taking an overdose and 23 a drug was found on the premises but you weren't 24 sure whether that was your drug or not, could you Page 73 1 send that to your lab and have them tell you 2 whether or not that was Fluoxetine? 3 MR. MYERS: Are you asking if that is 4 an example of a circumstance under which you 5 would ask for an assay? 6 MS. ZETTLER: Right. 7 A. Not necessarily, reask your 8 question again. 9 Q. Sure. Let me ask you this: 10 Can you tell from this document Exhibit 4, 11 whether or not this assay was done on Fluoxetine? 12 A. I can not, I would only be 13 guessing. 14 Q. Okay. Well, at the bottom -- 15 or I'm sorry, in the middle, it says calculations 16 and then over on the right-hand side it looks 17 like milligrams of Fluoxetine? 18 A. Okay, right, yes. I didn't see 19 that word Fluoxetine. 20 Q. That's okay. Then at the 21 bottom of the page, it says nightmares, nausea, 22 anxiety, constipation, stiff neck, asthenia, see 23 notebook, I believe -- 24 A. Yes. Page 74 1 Q. Number 191, pages 183, 184, and 2 185. Does this indicate to you that an assay was 3 done on this substance to see whether or not it 4 was Fluoxetine? 5 A. Yes. 6 Q. In what situation would that be 7 done, would that be done in a situation where 8 somebody was in possession of a drug but you 9 weren't sure if it was Fluoxetine or not? 10 A. We, from my recollection, Lilly 11 did not ask to have people send us things for 12 assays. 13 Q. Okay. Do you recall this 14 assay, this request? 15 A. No, uh-uh. 16 Q. Do you recall making any 17 requests on Fluoxetine? 18 A. Yes. 19 MR. MYERS: Assay requests? 20 MS. ZETTLER: Right. 21 A. Thank you. Yes. 22 Q. What types of situations would 23 you ask for assays on Fluoxetine? 24 A. If the patient or the person Page 75 1 who took it mailed us the pill and asked us to do 2 it. 3 Q. Okay. Would you do that for 4 somebody who was in a clinical trial, a blinded 5 clinical trial? 6 A. No. 7 Q. Would that be at least somebody 8 in post-marketing? 9 A. I am guessing that it is. 10 Q. At the bottom where it says see 11 notebook number 191, pages 183, 184, and 185, 12 what is that referring to? 13 A. I am guessing that it's a 14 notebook in the -- it's not my notebook, I know 15 that, so it's either in the CT area or maybe in 16 the lab. Honestly, I don't know whose notebook 17 that is. 18 Q. Okay. Is this your handwriting 19 where it says nightmares, et cetera? 20 A. No. 21 Q. Do you recognize the names on 22 the right-hand side? 23 MR. MYERS: Where on the right? 24 A. It looks like Nancy somebody Page 76 1 and -- no, I don't recognize either one of those 2 people. 3 Q. Is this your signature at the 4 bottom under requested by? 5 A. No. 6 Q. Do you know whose signature 7 that is? 8 A. No. 9 Q. Is it typical for somebody to 10 write your initial and last name on a request 11 such as this? 12 A. It would not surprise me 13 because up here it says submitted by Don Royston 14 or D. Royston and he was a department head in the 15 clinical trial or the CT area where people mailed 16 in actual product complaints and if a person 17 mailed him a pill with a complaint, then he would 18 have ordered this. And he could have called me 19 by phone and I said yes, that's fine with me, and 20 he could have put my name down. But I don't even 21 know that it was Don because that signature looks 22 different than even mine. 23 Q. Okay. When you say he was in a 24 department where -- that received actual product Page 77 1 complaints, what do you mean? 2 A. I need to think about how to 3 describe that clearly. Okay. If a vial -- for 4 example, if a vial of medicine had maybe a little 5 crack or a chip on the bottle, that's more of a 6 complaint about the product before the patient's 7 even taken it, it's not really related to adverse 8 event reporting. 9 Q. Q. So it's more of a complaint 10 with the quality of the product itself as opposed 11 to a reaction to the product? 12 A. It could be, right. 13 Q. Q. To your knowledge, were 14 there situations where a person would write in 15 saying, you know, for instance, I'm enclosing my 16 Prozac, it did this to me or made me feel this 17 way? 18 A. A. It's possible. Yes, that's 19 possible. 20 Q. Okay. What would happen with 21 that complaint, would that be forwarded then to 22 your department? 23 A. Yes, that complaint could have 24 come to our department first or to the CT area Page 78 1 first. I say CT, I may be using that 2 incorrectly, to that product area. Regardless, 3 we communicated together and we would -- they 4 would send that to us so that those events would 5 be reported. 6 Q. Okay. So for instance if 7 somebody sent back their Fluoxetine and said I 8 took this stuff and it made me suicidal, then you 9 would do an adverse event report, a 1639 on that 10 person's report of becoming suicidal? 11 A. Yes. 12 MS. ZETTLER: Can we take a break? 13 MR. MYERS: Sure. 14 (A SHORT RECESS WAS TAKEN.) 15 (PLAINTIFFS' EXHIBIT NO. 5 WAS 16 MARKED FOR IDENTIFICATION AND 17 RECEIVED IN EVIDENCE.). 18 Q. I realize, Leslie, that these 19 are signed by other people so I'm not going to 20 ask you about the content, I'm just going to ask 21 you more about the forms. 22 A. Okay. 23 Q. Are these the types of forms, 24 Exhibit 5, are these the types of drug experience Page 79 1 working forms that you used when you were in the 2 DEU? 3 A. Yes. 4 Q. Now it looks like there's 5 different types of working forms here. Like the 6 first page, it says drug experience report 7 working form and then at the top it says source T 8 or I for investigation, T for trial or I for 9 investigation? 10 A. Uh-huh. 11 MR. MYERS: Yes. 12 A. Yes. 13 Q. Q. Then a couple of pages, 14 three pages back there's another one that says 15 source, spontaneous, at the top. 16 A. Yes. 17 Q. Were there two separate working 18 forms for spontaneous reports as opposed to 19 trials or investigation reports? 20 A. Yes. 21 Q. What are the differences 22 between these two forms, if you can tell me? 23 A. I remember the working form for 24 spontaneous being blue and the trials were pink. Page 80 1 Q. Okay. How about as to the 2 types of information that the forms requested? 3 A. The types of information were 4 the same. 5 Q. Then the second page of Exhibit 6 5, was that -- is that part of the working form 7 itself? 8 A. I don't remember. 9 Q. Did you work with forms such as 10 the second page of Exhibit 5? 11 A. I have not worked with this 12 particular page before, I don't recall it. 13 Q. Okay. Did you work with a form 14 similar to the second page of Exhibit 5, in other 15 words one that asked for the event terms, things 16 of that nature? 17 A. The ones I worked with had both 18 terms, so you could put the words the person 19 actually reported and then underneath it would be 20 the ELECT term. 21 Q. Okay. Turn to the fourth page 22 of the exhibit, Pz 1980 1560, is that the form 23 you're talking about? 24 A. Yes. Page 81 1 Q. Would you use this form for 2 both spontaneous reports and clinical trial 3 reports? 4 A. When I was in the DEU, the 5 trial working form had a similar format where it 6 had both terms. 7 Q. Okay. But it wasn't this page, 8 page four? 9 MR. MYERS: The same form? 10 MS. ZETTLER: Right. 11 A. It could be the main difference 12 would be whether it was pink or blue. 13 Q. What's the difference, why were 14 some forms pink and some forms blue? 15 A. Just easy to identify. 16 Q. And the pink forms were the 17 spontaneous reports? 18 A. Trial. 19 Q. They were the trial reports. 20 They were essentially the same forms, just 21 different colors? 22 A. Yes, some other differences but 23 the content was the same. 24 Q. Like for instance on the Page 82 1 spontaneous reports, you wouldn't have a section 2 for the name of the trial or things of that 3 nature? 4 A. Correct. 5 Q. Okay. Was it to your knowledge 6 a policy at Lilly to list the most serious 7 adverse events first on the forms that you used? 8 A. If one of the events was 9 serious in terms of FDA criteria, that would go 10 first. 11 Q. Okay. If you look on the 12 second page of the exhibit at the top, it says 13 enter most important event first and all others 14 in order of decreasing importance. Do you recall 15 that being the policy when you worked in the DEU? 16 A. I don't recall that being a 17 policy when I was there. 18 Q. Okay. At bottom of the second 19 page, it has a little typewritten section that 20 says one, flag for weekly meeting, two, if event 21 is serious and expected, et cetera. 22 MR. MYERS: I don't think that word is 23 meeting. 24 MS. ZETTLER: Printing, I'm sorry. Page 83 1 Q. Was this something that you had 2 to do on the forms that you filled out also? 3 A. No. 4 Q. To your knowledge, were there 5 different forms you used at any time when you 6 worked in the DEU for adverse events related to 7 suicidality or violent-aggressive behavior? 8 A. Say that one more time, Nancy. 9 Q. Sure. To the best of your 10 memory, was there a specific form, separate form 11 used for adverse events regarding Fluoxetine that 12 were related to suicidal behavior or a violent 13 aggressive behavior? 14 A. From my recollection, no. 15 Q. What was -- if you received an 16 adverse event from a detail person, a Lilly 17 salesperson, what was the policy for how that 18 event was recorded as far as who reported it? 19 MR. MYERS: When you say who reported -- 20 Q. In other words -- look at the 21 first page of the exhibit, okay, it has a space 22 at the bottom right-hand corner which is 23 basically blacked out for initial reporter. 24 A. Uh-huh. Page 84 1 Q. You have to say yes or no. 2 A. Yes. 3 Q. Would the detail person's name 4 be listed there? 5 MR. MYERS: Wait a second, this is a 6 trial report, so maybe that's not a good example. 7 Q. In an adverse event that was 8 reported by a detail person, was that detail 9 person's name recorded anywhere on the working 10 form? 11 A. I don't remember. 12 Q. Was it listed on the final 1639 13 that was sent to the FDA? 14 A. No. 15 Q. Whose name would be listed as 16 the initial reporter on the 1639? 17 A. I don't remember. 18 Q. In the case of the first page 19 of the exhibit, as Larry pointed out, this is a 20 working -- report working form for an adverse 21 event that occurred in a clinical trial. Would 22 the -- whose name would be listed as the 23 reporter, would that be the clinical 24 investigator? Page 85 1 A. The investigator had a number 2 and -- I believe it was like a number, but on the 3 one that was printed, I don't know what would go 4 in that box, I just don't remember. 5 Q. Have you ever seen an adverse 6 event report resulting from an adverse event 7 occurring in a clinical trial where the 8 reporter's name was the clinical investigator on 9 that trial? 10 A. I don't remember ever seeing 11 that. 12 Q. Do you remember that not being 13 the case, that the clinical investigator would 14 not be listed as the initial reporter on the 15 1639? 16 MR. MYERS: The final 1639? 17 MS. ZETTLER: Right. 18 A. I don't recall, I just don't 19 know. 20 (PLAINTIFFS' EXHIBIT NO. 6 WAS 21 MARKED FOR IDENTIFICATION AND 22 RECEIVED IN EVIDENCE.) 23 Q. Have you ever seen forms, and 24 again I realize that your name is not on here as Page 86 1 a person who signed this, but have you ever seen 2 a form similar to this when you were working in 3 the DEU? 4 A. No. 5 Q. How about the third page of the 6 form, have you ever seen those types of 7 narratives before? 8 A. No. 9 Q. Were you ever aware that these 10 types of reviews were being done at Lilly on 11 suicide and Fluoxetine? 12 A. No. 13 (PLAINTIFFS' EXHIBIT NO. 7 WAS 14 MARKED FOR IDENTIFICATION AND 15 RECEIVED IN EVIDENCE.) 16 Q. Have you had a chance to review 17 Exhibit 7? 18 A. Yes. 19 Q. Have you seen this form before? 20 A. Yes. 21 Q. Can you tell me what it is? 22 A. This form is a request to 23 change information in the DEN system. 24 Q. What type of information? Page 87 1 A. It looks like the reporting 2 date. 3 Q. For this particular form? 4 A. With this particular form, 5 right. 6 Q. In what circumstances would you 7 use this form? 8 A. If a 1639 that was printed and 9 the information entered into DEN, if the 10 information that was entered did not match the 11 source document, perhaps a typo or something, and 12 we wanted to change that and correct the typo, 13 then we would do this kind of a form. 14 Q. When you say the source 15 document, you mean the working 1639? 16 A. Yes. 17 Q. Did you ever make substantive 18 changes on 1639s by using this form, in other 19 words changing event terms, things of that 20 nature? 21 A. I don't remember doing that. 22 Q. Do you know, if you were going 23 to change an event term, could you use this form 24 to do it? Page 88 1 A. I don't know if you can change 2 an event term or not. 3 Q. With the form? 4 A. With this form, right. 5 Q. Would you go back to Exhibit 2. 6 As reflected in Exhibit 2, were you reviewing 7 working 1639s that were sent in by the 8 affiliates, like for instance on the first page, 9 the French affiliate? 10 A. Right. 11 Q. Was that working 1639s or were 12 those the computer 1639s? 13 A. They were a computer 1639 but 14 because they were from an affiliate, they're kind 15 of working forms through the computer, if you 16 would. 17 Q. So it's a computerized working 18 form, so to speak? 19 A. I thought of them as that. 20 Q. Okay. Was the form similar to 21 the working forms, the working report forms 22 reflected in Exhibit 5 or was the form closer to 23 the final 1639 that was passed out or that was 24 passed on to the FDA? Page 89 1 A. Right, they were more closely 2 related to the actual form 1639. 3 Q. Okay. If you had, such as 4 reflected in Exhibit 2, asked for instance 5 Frederique to change -- like here it says please 6 mark overdose as an outcome for each event term 7 of overdose, make an addition or change such as 8 that to a 1639. Would this type of form that's 9 reflected in Exhibit 7 have to be filled out? 10 A. No. 11 Q. They could just go in and do it 12 on the computer? 13 A. I don't know how the affiliate 14 did it, but they could change it. 15 Q. Okay. And the -- was the final 16 1639 printed up from Indianapolis or was it 17 printed up from the affiliate? 18 A. Indianapolis. 19 Q. Do you recall a situation where 20 a change was made on a 1639 in Indianapolis 21 without consulting with the affiliate first? 22 MR. MYERS: On a report from the 23 affiliate? 24 MS. ZETTLER: Right. Page 90 1 A. I don't recall any. 2 Q. On Exhibit 7, it says DFC 3 change. What's a DFC change, data field? 4 A. It must be data field change. 5 Q. What does it mean there by 6 delete, DFC change slash delete request? 7 A. If a particular 1639 was to be 8 deleted from the data base, you would use this 9 form. 10 Q. So you could delete an entire 11 1639 using this form or request that a deletion 12 be made, be done? 13 A. Yes. 14 Q. In what situations would a 1639 15 be deleted from the data base? 16 A. If that particular report had 17 already been reported and you had one event 18 reported twice under two DEN numbers. 19 Q. So one of them would then be 20 deleted? 21 A. Yes. 22 Q. Which one would be deleted, the 23 first or the second or would it vary? 24 A. I don't remember. Page 91 1 Q. Okay. Besides taking and 2 reporting adverse event reports and reviewing the 3 1639s for instances of violent-aggressive 4 behavior, neuroleptic malignant syndrome, and 5 aplastic anemia, did you have any other 6 responsibilities when you were a CRA in the DEU? 7 A. As new people came in, I would 8 be a mentor or train, I presented adverse event 9 reporting kind of classes to the sales force. 10 What else did I do -- I went to meetings. I 11 can't recall any other responsibilities. 12 Q. Okay. When you say you went to 13 meetings, what types of meetings would you go to? 14 A. We had staff meetings, we had 15 meetings related to the particular compound that 16 we were assigned to which would be our focus and 17 for me it was Insulin and DES and I would go to 18 meetings associated with those two products. And 19 those meetings could be varied for various 20 reasons. Nancy, I don't remember the other 21 reasons for meetings. 22 Q. Did you attend any Prozac 23 meetings or Fluoxetine meetings? 24 A. I don't remember any because Page 92 1 that wasn't my focus compound, my assignment. 2 Q. If your focus was Insulin and 3 DES, how is it that you ended up working on some 4 Fluoxetine adverse events? 5 A. Each day we would get a certain 6 number of reports, adverse events that had to be 7 entered in the system, and we tried to have those 8 in very, very quickly and so we would divide 9 those up among all of us that came in on a daily 10 basis so that the work would be evenly 11 distributed. 12 Q. How is it that you ended up on 13 the Prozac safety team if your focus was Insulin 14 and DES? 15 A. I don't remember specifically 16 how I ended up there. 17 Q. Did somebody tell you that you 18 were going to be involved in that project? 19 A. I just don't remember. 20 Q. What percentage of your time 21 would you say, while you were in the DEU, was 22 spent working on Fluoxetine as opposed to the 23 other drugs you worked on? 24 A. Probably about -- maybe Page 93 1 twenty-five or thirty percent and that was just a 2 focus of filling out the 1639s. 3 Q. Okay. Do you recall any 4 differences in the way adverse events that came 5 in on Fluoxetine were reported as opposed to 6 adverse events that came in on any other of the 7 drugs you worked on? 8 A. No. 9 Q. Okay. Then you moved to 10 quality assurance, correct? 11 A. Yes. 12 Q. Why did you make that move? 13 A. It was time for a move, I guess 14 I was a little tired with filling forms out. 15 Q. Then you got to go to QA, 16 right? 17 A. Right. 18 Q. And you left -- you started in 19 quality assurance in January of '91, correct? 20 A. Correct. 21 Q. Did you have a specific title 22 in quality assurance? 23 A. It's just quality assurance 24 representative. Page 94 1 Q. Did you make a specific request 2 to be moved to quality assurance or did you ask 3 for a change in duties? 4 A. I asked for a change and this 5 position was open. 6 Q. Who did you interview with to 7 make that change? 8 A. I interviewed with Ardith 9 Hieber and Marty Hynes, Ann Fulk. 10 Q. Would you spell the first name, 11 please? 12 A. Ardith, A-R-D-I-T-H, I think. 13 Q. And last name? 14 A. Hieber, H-I-E-B-E-R. 15 Q. And Ann's last name? 16 A. F-U-L-K. 17 Q. Anybody else? 18 A. I think -- well, I talked to my 19 personnel representative at that time, and I 20 don't remember that person's name, I think that's 21 all. 22 Q. Who's Ardith Hieber? 23 A. Ardith Hieber was a department 24 head at that time in the Quality Assurance Page 95 1 Department. 2 Q. And Marty Hynes? 3 A. He is the director, H-Y-N-E-S. 4 Q. So he was the director of QA? 5 A. Yes. 6 Q. Who was Ann Fulk? 7 A. She was the Executive Director 8 who's over Marty then. 9 Q. Okay. So the chain of command 10 would have been Ardith Hieber, Marty Hynes, Ann 11 Fulk, going up? 12 A. Yes. 13 Q. Do these three people still 14 work for Lilly, to your knowledge? 15 A. Yes, they work for Lilly. 16 Q. Are they still in QA? 17 A. Ardith Hieber is not. 18 Q. Where is Mr. Hieber, is that a 19 man or woman? 20 A. A woman. 21 Q. Where is Ms. Hieber? 22 A. She -- the last time I knew, 23 she is in the Drug Epidemiology Unit now. 24 Q. Did they make a swap, you for Page 96 1 her? 2 A. Well, she's a department head 3 so she's got more -- 4 Q. She decided she wanted to start 5 filling out forms? 6 A. Yes. 7 Q. Were you assigned specific 8 drugs when you were in QA -- in other words 9 working on specific trials and drugs? 10 A. Yes. 11 Q. Which drugs? 12 A. Okay. When I first came, I was 13 on the oncolitics or cancer related drugs and 14 then I think I did -- I think I did the Insulins 15 for a little while and now I have the Lilly 16 Clinic. 17 Q. Any others? 18 A. No, I don't remember any 19 others. 20 Q. Were you ever assigned 21 specifically to Fluoxetine? 22 A. No. 23 Q. You did work -- you did do one 24 quality assurance review of a Prozac or Page 97 1 Fluoxetine trial though, did you not? 2 A. Yes. 3 Q. Just the one? 4 A. I think I did more than one but 5 I just -- again, I don't remember. 6 Q. Okay. Tell me generally what 7 your responsibilities as a QA representive were? 8 A. Okay. Seems like they're 9 almost similar. We do some education of other 10 Lilly employees related to quality assurance, we 11 do consulting, so if a person at Lilly has a 12 question related to quality assurance things, 13 then we try to give them an answer and then we do 14 audits of different investigators, we do audits 15 of our own departments within Lilly, and that's 16 pretty much all of the responsibility. 17 Q. What departments would you do 18 audits on at Lilly? 19 A. I just did one at the Lilly 20 Clinic. We could do one of any -- well, not any 21 department, the medical department, we could do 22 one of that, we could do anything really related 23 to the medical part. 24 Q. Okay. When you say you did an Page 98 1 audit of the Lilly Clinic, was it the clinic in 2 general or was it related to a trial that was 3 going on there? 4 A. Both, kind of in general and 5 then some trials that they had done in the past. 6 Q. And when you say you would do 7 an audit of medical department, what types of 8 audits would you do in there? 9 A. Whatever we decided to define 10 it as, it could be -- let me see if I can guess, 11 if there's an example. We might look -- we would 12 look through our company's policy book, pick out 13 a policy and then see what that policy requires 14 and then just do an audit to see if that 15 particular department is following that policy. 16 Q. Can you give me a more specific 17 example of what you mean? 18 A. For instance, a policy requires 19 certain documents to be in a particular folder, 20 then we would look at that policy and the 21 procedure related to it and then look at that 22 document to see that they were following what 23 they were supposed to follow. 24 Q. Are these audits that you do Page 99 1 announced or unannounced? 2 A. Announced. 3 Q. If you were going to do an 4 audit in the medical department, who would you 5 notify that you were going to audit? 6 A. I would -- we would notify the 7 people, the direct workers and then maybe the 8 department head and the manager, probably even 9 the director, I think. 10 Q. Was there a quality assurance 11 rep or reps that were specifically assigned to 12 Fluoxetine? 13 A. Well, yes, but it was more like 14 the central nervous system, it's more -- it 15 wouldn't be just Fluoxetine, it would be drugs 16 related to a particular cluster so that the 17 cluster or the working team would have a quality 18 assurance rep assigned to their cluster. 19 Q. Who were the quality assurance 20 reps assigned to the CNS cluster? 21 A. I don't know who that person 22 is. 23 Q. How many people are in your 24 department? Page 100 1 A. Probably about -- there's 2 probably maybe five or six of us. 3 Q. Can you give me some of those 4 other names? 5 A. Rick Huddleson, Debbie 6 Steinkurtz, Cheryl Sunman. Jim Eggert is our 7 department head presently -- or excuse me, he's a 8 manager, we don't have a department head. Jim 9 Satoris and Debbie Jeffries is the newest person 10 and those are the people who are in there now. 11 Q. How about Vicky Thompson? 12 A. No, Vicky is not in our 13 department. 14 Q. When you did an audit at the 15 site, clinical invesitation site, would those be 16 announced or unannounced? 17 A. They're announced. 18 Q. Did you ever -- do you work 19 with anybody from the FDA in your position in 20 quality assurance? 21 A. No. 22 Q. Are you aware that the FDA does 23 periodic audits of sites themselves? 24 A. Yes. Page 101 1 Q. Do they do periodic audits of 2 like, for instance, the medical department at 3 Lilly? 4 MR. MYERS: Are you asking her if the 5 FDA can come in and audit the medical department 6 at Lilly? 7 A. Yes, they can. 8 Q. Have you ever seen where 9 they've done that? Have you ever been aware of a 10 situation where they've come in and audited the 11 medical department? 12 A. They recently -- actually just 13 recently were in the medical department at Lilly. 14 Q. Do you know why they were 15 there? 16 A. It was for another compound. 17 Q. Other than Fluoxetine? 18 A. Yes. 19 Q. Are you aware of an occasion 20 where the FDA came to the Lilly medical 21 department and audited it related to Fluoxetine? 22 A. No. 23 Q. When they come and do an audit 24 such as the one they just did recently, is that Page 102 1 an announced or unannounced visit, if you know? 2 A. I think it was announced, we 3 knew ahead of time. 4 Q. And was that just a routine 5 audit or were they there for a specific reason? 6 You don't have to tell me what the reason is. 7 A. They were there, they had a 8 specific reason. 9 Q. Have you heard of a four-cause 10 audit? 11 A. Yes. 12 Q. Was it a four-cause audit? 13 A. No. 14 Q. What is a four-cause audit? 15 A. I think when they have specific 16 reason or prior knowledge of some event which 17 leads them to come for a four-cause audit. 18 Q. There's another department at 19 Lilly that regulates the quality of clinical 20 trials, correct, the CIRs I think they are? 21 A. Would you restate that 22 question? 23 Q. Sure. Is there another 24 department at Lilly or another group of employees Page 103 1 besides quality assurance that will go to a site 2 and double check the quality of the work that's 3 being done at the site? 4 A. Yes. 5 Q. What department is that? 6 A. Well, it's within the medical 7 department. 8 Q. And those individuals I think 9 are called CIRs, does that sound familiar? 10 A. Yes. 11 Q. What's the difference between 12 their function and your function? 13 A. The CIRs go to the site on a 14 routine, pretty much a set basis, and they look 15 to see that the investigator is entering the 16 data, is following the format of the case report 17 form. They also look to see that they are doing -- 18 the data is accurately reported on the case 19 report form. 20 Q. Okay. How does that differ 21 from your function? 22 A. Our function is more one where 23 we don't go out and do an audit of every single 24 investigator on every single trial. Also I see Page 104 1 ours as more detailed. 2 Q. What situation would you audit 3 a site? 4 A. If -- there are several things 5 that would send us to go do an audit and that 6 would be if the medical department requests us to 7 do one or if we're doing clinical trials, we want 8 to do a certain percentage of all investigators, 9 and then if the FDA -- if we know that the FDA is 10 going to go out to a site, then we do what we 11 call a pre-FDA audit, but then we just look at 12 regulatory documents, we don't really -- and just 13 kind of make sure they have all their documents 14 in kind of neat order. 15 Q. Does the FDA ever make 16 unannounced visits to clinical trial sites? 17 A. I think they have the right to. 18 Q. Has it been your experience 19 that they do do that, or is it generally they 20 notify you before they go out there? 21 A. Generally we have some idea a 22 little beforehand. 23 MS. ZETTLER: Okay. Let's take a short 24 break. Page 105 1 (A SHORT RECESS WAS TAKEN.) 2 Q. Before we get too deeply into 3 the quality assurance, let me ask you couple of 4 quick questions about the DEU. You said that 5 when you were in the DEU, one of your 6 responsibilities was teaching? 7 A. Yes. 8 Q. What types of things would you 9 teach or who would you teach, generally? 10 A. The ones I remember is to the 11 newly trained or the sales representatives being 12 trained and we would just present kind of a half 13 hour overview of their reporting responsibilities 14 related to adverse events on any Lilly product at 15 all. 16 Q. Okay. Would you give them 17 written materials? 18 A. Yes, I do remember some written 19 material. 20 Q. What types of written 21 materials? 22 A. I remember like a little pocket 23 card, a little plastic laminated card that they 24 had available to them. Page 106 1 Q. For what? 2 A. It would just give them the 3 phone number to call, our phone number, and it 4 had the serious criteria and had just basically 5 like the definition of an adverse event and they 6 were to call here, you know, call our unit. 7 Q. Any other written materials 8 that you can remember? 9 A. None that I can remember. 10 (PLAINTIFFS' EXHIBITS NOS. 8, 9 11 and 10 WERE MARKED FOR 12 IDENTIFICATION AND RECEIVED IN 13 EVIDENCE.) 14 Q. Okay. Have you had a chance to 15 review these Exhibits, 8, 9 and 10? 16 A. Yes, Nancy. 17 Q. Do you recognize these 18 documents, Leslie? 19 A. Yes. 20 Q. Are these documents all related 21 to the same site audit? 22 A. It seems, yes. 23 Q. And this is a Fluoxetine study, 24 I take it? Page 107 1 A. Yes. 2 Q. Okay. Look at Exhibit 8, who's 3 Gary Lightfoot? 4 A. Gary Lightfoot is presently in 5 charge of overseeing a group of people who hire 6 CROs, who do clinical trials for us. So he's 7 either a manager or director level, I'm not quite 8 sure what level. 9 Q. What's a CRO? 10 A. It's a contract research 11 organization. 12 Q. Okay. So the contract -- the 13 research organization will hire clinical 14 investigators or -- 15 A. Sometimes, but most often they 16 have their own investigators and they do the 17 trial right there. 18 Q. Okay. Have you ever heard of a 19 Doctor Feighner? 20 A. No. 21 Q. Are you familiar with any CROs 22 that worked on Fluoxetine? 23 A. No. 24 Q. Is the site that's the subject Page 108 1 of this audit a CRO? 2 A. No. 3 Q. What did Mr. Lightfoot do prior 4 to being in charge of the department that hires 5 CROs? 6 A. He was in charge of the people 7 who hire investigators to do clinical trials. 8 Q. The CRCs? 9 A. Yes. He was the head of the 10 CRCs, and actually that department kind of went 11 into two ways so -- but Gary was in charge of the 12 CRCs. 13 Q. Okay. How about S. M. 14 Harrill? 15 A. Who. 16 Q. Looks like Mike Harrill, I 17 think this is? 18 A. Okay. Mike Harrill, he -- I 19 think he's also -- he was either a manager or a 20 director in the medical area. 21 Q. Do any of these people that are 22 listed in the CCs on the first page of Exhibit 8, 23 were they in your -- the QA department? 24 A. Okay. J.B. Scotton was in the Page 109 1 quality assurance department in Erl Wood which is 2 in Europe. Maeda, Maedason, we always say son 3 because she's Japanese, is in the quality 4 assurance department in Japan. Marty Hynes is 5 the director in my department, Ardith Hieber the 6 department head at that time, Ann Fulk is the 7 executive director. And that's all in my quality 8 assurance department. 9 Q. Okay. Why would quality 10 assurance people from Japan and Erl Wood be 11 carbon copied on this audit? 12 A. Because they CC us on theirs 13 too, it's just a way to keep communications open 14 between affiliates, so we can just keep 15 communications open. 16 Q. This study was on long-term 17 treatment of major depressive disorder, correct? 18 A. Yes. 19 Q. And do you know if this was a 20 multi-site study or a single site study? 21 A. I don't remember. 22 Q. Would a multi-site study have 23 arms in the United States as well as outside the 24 U.S.? Page 110 1 A. It could be, it could be 2 outside and it could be just in the United 3 States. 4 Q. Is this audit just of one 5 investigator? 6 A. Yes. Yes, because they all 7 have the same number, looks like, have a common 8 number. But without the, you know, with the 9 black out it's pretty hard to tell. 10 Q. Do you recall this audit 11 independent of these documents? 12 A. Not independent of these 13 documents. 14 Q. Okay. Can you give me an idea 15 of how an audit is conducted, a QA audit? 16 MR. MYERS: Of a site? 17 MS. ZETTLER: Yes. 18 A. We'll look in the folder of -- 19 the CRA's folder in Lilly and she keeps documents 20 related to various things related to the site, 21 communications between the medical department. 22 Q. Would that be the investigator 23 side? 24 A. Yes, yes, and we go to that Page 111 1 binder and we look at different things just to 2 get a general flavor for the relationship and 3 what we want them to do. We read the protocol 4 and then we go out to the site and we look at 5 what we call a regulatory binder or the 6 investigator's regulatory files, and we look to 7 make sure that the proper documentation is there, 8 that the protocol was submitted to the IRB and 9 all those different kinds of regulatory 10 documents. Then we'll take the case report form 11 and compare the information on it, and compare it 12 to the source documents or the patient's medical 13 records, and make sure that the correct 14 information was put into the case report form. 15 And then if the site -- and I think this one may 16 have had what we call a CTM or computer data 17 site, then we'll compare the case report form 18 things to the CTM printout as well. 19 Q. Okay. So in that situation, 20 there would be a hard copy CRF that would be 21 transferred to the CTM by the investigation site? 22 A. Yes. Now, they don't -- in 23 cases of CTM, they don't call it a case report 24 form and I used that word in a generic sense, so Page 112 1 excuse me, now they call it the CTM worksheet, 2 but it has the same purpose as a case report 3 form. 4 Q. What does CTM stand for? 5 A. Clinical trial and I don't know 6 what the M stands for. 7 Q. All right. You said at the 8 beginning that you looked at -- originally you 9 would look at the CRA's investigator file? 10 A. Uh-huh. 11 MR. MYERS: Yes. 12 A. Yes. 13 Q. And you looked at different 14 things within the file to get a flavor for what 15 the study was about? 16 A. Yes. 17 Q. What types of things would you 18 look at besides the protocol? 19 A. I would look at the form that 20 went to the FDA that advises the FDA that we're 21 doing this study and I would look to see what 22 investigators are listed on this particular 23 little square. 24 Q. Is that the 1573? Page 113 1 A. 1573 or 1572, something in 2 there. And I would look at the labs and the 3 hospital or the the site where the subjects will 4 be seen, I would look for a CV for each of the 5 physicians listed, I would look at the, what do 6 you call it, the shipping records to see what 7 drug, clinical trial material had been shipped to 8 the site, I look for any amendments to that 9 protocol and I make a note of those. And then 10 when I go to the site, I make sure that they have 11 the same amount or the same information in their 12 file so that the files are compatible with each 13 other and don't conflict and there's -- both 14 people have the same information. 15 Q. So they would have -- the site 16 would have a file, investigator file similar to 17 the CRA file? 18 A. Yes, it would be similar. 19 Q. Is this the regulatory file you 20 were talking about or is that something 21 different? 22 A. No that's what I call it, the 23 regulatory file. 24 Q. And that would include the Page 114 1 C.V.s, the 1573s or 1572s, the protocol, things 2 of that nature? 3 A. Right. 4 Q. Would the investigator's file 5 contain grant information? 6 A. In-house, it would. At the 7 site, the investigator usually puts that in a 8 separate file. 9 Q. Okay. Was there any 10 information kept in the investigation site file 11 that was not kept in the CRA file? 12 A. There could be. If the 13 investigator chooses to put some kind of 14 information, he could. 15 Q. But the stuff you just listed 16 is the stuff that's required by Lilly? 17 A. Yes -- I'm sorry repeat that. 18 Q. The information in the document 19 you just listed for me, the different types of 20 1573s, and protocols, et cetera, were those 21 documents required to be kept in the regulatory 22 file at the site by Lilly, was that Lilly's 23 requirement? 24 A. It's Lilly's and then I think Page 115 1 it's the government's, too, that you have to at 2 least be able to produce those documents. Now 3 whether the investigator kept it in a file or 4 shoe box didn't matter a whole lot to me as long 5 as he had them and they were easily found in some 6 kind of of logical sequence. 7 Q. Would the IRB approval be 8 included in that group? 9 A. Yes. 10 Q. And periodically I believe the 11 FDA requires that IRBs rereview what's been going 12 on at the study and reapprove and things of that 13 nature? 14 A. Right, yes, that's correct. 15 Q. Then you said the next thing 16 you do would be to compare the clinical report 17 forms with the source documents outside of 18 whether or not it was computerized or not? 19 A. Yes. 20 Q. What type of source documents 21 would they typically have at the sites? 22 A. Well, some sites will have the 23 patients or subjects past medical records and I 24 would review those. They would have -- we like Page 116 1 them to have some kind of source document that 2 when the patient came to the visit that they 3 wrote down that they saw the patient and some 4 basic information. There would be maybe EKGs and 5 chest x-rays, the original copies of those that 6 were taken related to the study, drug 7 accountability records where they were given the 8 CT material and those should be kept and there's 9 a place in the case report form also. So those 10 are the source documents that I would look at. 11 Q. With regards to the Fluoxetine 12 studies that you worked on, would they have 13 source documents or forms separate from the CRFs 14 with regards to like the Hamilton depression 15 rating scale or any of the scales that were 16 administered or psychiatric tests that were 17 administered in the clinical trials? 18 MR. MYERS: Who is they? 19 MS. ZETTLER: The site. 20 A. The site. Those scales were 21 kept -- they were like part of a folder, part of 22 the case report form type information. 23 Q. So when they administered those 24 tests, they would, in effect, record the results Page 117 1 right out of the CRF as opposed to filling out 2 another form and transferring the information to 3 the CRF? 4 A. I don't know. 5 Q. Do you recall seeing a 6 situation where there would be a form used to 7 record answers or responses to questions as 8 during the administration of a test and then 9 transfer it onto the CRF? 10 A. I don't remember recalling 11 those. 12 Q. The same as far as comparing 13 the source documents with the CRF, if it had 14 computerized CRFs, in effect it would just be one 15 more step, you would check the source documents 16 against the CTM worksheet and then the work sheet 17 against the computer? 18 A. Repeat that one more time. 19 Q. If you had a site that's using 20 the CTM. 21 A. Okay. 22 Q. Would you have to check the 23 original source documents against the CTM 24 worksheet and then check the CTM Page 118 1 worksheet against the computerized CRF? 2 A. Yes. 3 Q. That would be done at the site? 4 A. I would do that, yes. 5 Q. Is that something that was done 6 across the board within quality assurance as far 7 as you know? 8 A. Yes. 9 MR. MYERS: In those instances where 10 there was a CTM trial? 11 MS. ZETTLER: Right. 12 A. Yes. 13 Q. Let me ask you this, what types 14 of deficiencies, for lack of a better phrase, 15 would you be looking for? 16 A. I would be looking for from the 17 regulatory documents to see if they had each, the 18 proper IRB papers and they were signed and if 19 there was a form there -- if there was any 20 amendments, if they had the amendments approved 21 by the IRB and I would again look for their drug 22 shipments and make sure that they got the drug 23 that their form said they had. And so if they 24 didn't have any of that information, then that Page 119 1 would be a deficiency. 2 Q. Any others? 3 A. As far as regulatory documents? 4 Q. No. If there are others with 5 regards to regulatory, sure, but I'm just 6 generally trying to get an idea of the types of 7 things you looked for. 8 A. Say in the CTM situation, on 9 the CTM worksheet, they may have a blood pressure 10 of a hundred and twenty and then when it was 11 keyed in to the computer, it may say a hundred 12 twenty-two, so then I would note those little 13 things and then ask them to make a correction to 14 the hundred and twenty. 15 Q. Okay. Any other deficiencies 16 with regards to the regulatory documents? 17 A. Well, if they didn't have a 18 C.V. for each physician or investigator involved 19 in the study, then I would ask them to get the -- 20 show me some kind of a C.V. and put it with the 21 documents. 22 Q. Other than documents being 23 missing from the file? 24 A. Okay. Page 120 1 Q. Would you look at it to see if 2 the documents were completed correctly? 3 A. Yes. 4 Q. What types of -- what were the 5 most common deficiencies that you would find with 6 regards to the regulatory documents? 7 MR. MYERS: Are you talking now about 8 the Prozac audits that she's done? 9 MS. ZETTLER: Yes. 10 A. Oh, I couldn't say. 11 Q. How about generally in audits, 12 without telling me about a specific study or 13 drug, I'm just trying to get an idea. 14 A. There may be -- they may have 15 forgotten if they have three investigators, and 16 they may have two C.V.s and they simply go to 17 their secretary's desk and pull out another C.V. 18 and stick it in. So, it's usually just real 19 simple things that can be just corrected by 20 pulling out a document out of somewhere. 21 Q. What about with regards to 22 documentation of patients participating in the 23 studies, what kinds of deficiencies were you 24 looking for in your audit? Page 121 1 A. Okay. And this is in any 2 audit? 3 Q. Well, if you know of a 4 difference between Fluoxetine, and in general, 5 I'm just trying to get a general feel of how the 6 audits were conducted. 7 A. I would -- I always looked to 8 see that the patients signed the consent prior to 9 anything being done related to the protocol, any 10 protocol requirements, okay. I always looked to 11 see that the protocol is being followed, it's 12 kind of like a recipe, to make sure that 13 everything is done. I always looked to make sure 14 that any adverse event is reported, make sure 15 that any historical medical information or any 16 other medication the patient may be taking is 17 recorded properly. 18 Q. Anything else? 19 A. No. It seems like I looked for 20 a lot but that pretty well is kind of an overview 21 of everything that we do. 22 Q. So you wanted to make sure that 23 the consent forms were signed and witnessed? 24 A. Yes. Page 122 1 Q. Check for any protocol 2 violations with regards to any given patient? 3 A. Yes. 4 Q. And double check to make sure 5 that there weren't any adverse events that were 6 recorded or memorialized somehow within the 7 documents that were not reported? 8 A. Correct. 9 Q. And make sure that there was a 10 proper reporting of any historical medical 11 information? 12 A. Yes. 13 Q. When you say historical, you 14 mean before the person began participating in the 15 clinical trial or do you mean like week by week? 16 A. I mean prior to entering the 17 trial. 18 Q. Okay. Protocol violation might 19 encompass something along the lines of say a 20 concommitant drug not being carried over into the 21 next week, things of that nature, right? 22 A. Yes. 23 Q. Would you look at Exhibit 8 24 again, the second page. I notice that the date Page 123 1 at the top is April 17, 1992, and the date of the 2 original audit is October 15th through 17th, 3 1991. Why is there such a gap between the time 4 of the original audit and the time of this 5 report? 6 A. I don't know. 7 Q. Is that typical? 8 A. It's possible. 9 Q. It's possible that it's typical 10 that there would be such a gap? 11 A. It's not typical. 12 Q. And the synopsis that starts on 13 the next page, the synopsis of the QA audit 14 report? 15 A. Yes. 16 Q. Is this a form that's typically 17 used with the audits? 18 A. Yes. 19 Q. What is this form, is this 20 something that is done at the beginning or at the 21 end or in the middle? 22 A. This is -- this page is 23 generated when the audit is first entered into -- 24 entered or typed up and then mailed to everybody Page 124 1 and it stays the same until -- even though it's a 2 final audit report so it's kind of a face sheet. 3 Q. So it's like almost like a 4 writing type sheet? 5 A. Yes. 6 Q. And keeps you -- it's 7 consistent throughout the entire process? 8 A. Yes. 9 Q. Can you tell me where these 10 three exhibits fit in with each other, Exhibit 8, 11 9 and 10? 12 A. Okay. Let's see if I can even 13 piece it together. This is response to the 14 November 18, 1991. 15 Q. That's Exhibit 9? 16 A. That must go with 1232 of 17 November of '91 here, which is 8. 18 Q. When you say 1232, you say -- 19 A. That's the audit number. 20 Because the dates are the same or at least the 21 November,'91 is. Oh, okay, on the back of 22 Exhibit 9, it looks like -- oh, that's our 23 request, okay. 24 Q. What was that, what's the back Page 125 1 of Exhibit 9? 2 A. It looks like it says audit 3 response request and that's that we asked them to 4 respond to these seven questions. 5 Q. How are these seven questions -- 6 at what point within the process are these seven 7 questions formulated? 8 A. After we do the audit and we 9 bring the information back to our office and we 10 kind of look it over and try to see if we find 11 any problems or observation that was maybe 12 observed more than once. 13 Q. Okay. And then somebody, 14 either yourself if you're involved or like Jim 15 Satoris in this case or whatever, people that are 16 listed as auditors on the right hand -- upper 17 right-hand side, would formulate these questions? 18 A. Yes. 19 Q. And then they would be 20 transferred to who for answering? 21 A. We sent this one -- well, let's 22 read the address and see, looks like we sent it 23 to Mike Harrill and Gary Lightfoot. 24 Q. Why would Mister Harrill and Page 126 1 Mister Lightfoot respond to these questions or be 2 asked to respond to these questions? 3 A. Because they were managers or 4 directors and I'm not quite sure which one they 5 are of the particular area in medical that was 6 involved with this clinical trial. 7 Q. Okay. Mister Harrill was a 8 director in medical, you weren't sure which 9 department, and Mister Lightfoot I think you said 10 at that time was a CRC head? 11 A. Correct. 12 Q. And they were authorized to 13 make these types of decisions, like for instance 14 on the last page of Exhibit 9, first question, 15 how and when appropriate changes to the CRF will 16 be made? 17 A. Yes. 18 Q. Would a -- would they have to 19 work through a clinical research physician to 20 answer any of these questions? 21 A. No, they probably would go to 22 the CRA or the CIRs, people who worked for them. 23 Q. But if they had to make a 24 decision, for instance with the first question Page 127 1 again, as to when appropriate changes to the CRF 2 will be made, they could make those decisions? 3 A. Yes. 4 MR. MYERS: Are you talking about the 5 persons to whom the questions are addressed? 6 MS. ZETTLER: Right, Harrill and 7 Lightfoot. 8 Q. And towards the beginning of 9 actually the front of Exhibit 9, the first page, 10 it says attached please find response to the 11 November 18, 1991, MQA audit report. And this is 12 at least Mister Lightfoot's response to some of 13 those questions, correct? 14 A. Yes. 15 Q. That would be the second page 16 of Exhibit 8? 17 A. Yes. 18 Q. And the same with the third 19 page, looks like it's answering a couple of 20 questions, looks like question one and question 21 seven are answered on the second page or the 22 third page of the exhibit? 23 A. Yes. 24 Q. What would be done after these Page 128 1 questions were answered? 2 A. One of two things can be done: 3 We can accept their answers and go about looking 4 at other investigators, or if we wanted to we 5 could go back out and check to make sure that 6 these answers -- what they said they would do in 7 their answers were done. 8 Q. So is it then Mister Lightfoot 9 and Mister Harrill's responsibility to make sure 10 that all of these things were carried out at the 11 site? 12 A. Yes. 13 Q. Do you remember with regards to 14 this particular audit whether or not all of these 15 items were carried out, the items listed in 16 Exhibit 9? 17 MR. MYERS: The response? 18 MS. ZETTLER: The response and the 19 questions, I guess. 20 A. Yes. I didn't go back out for 21 a follow-up audit on this particular one so I 22 can't say that absolutely each and every thing 23 was corrected at the site. 24 Q. To your knowledge, did anybody Page 129 1 go out and do a follow up audit? 2 A. Yes, I think there was one. 3 Q. Do you remember who 4 participated in that follow-up? 5 A. No. 6 Q. So was that pretty much the 7 procedure with regards to audits, you guys would 8 go out there and do the audit, come back and 9 formulate questions and route those questions to 10 the people you felt were the best able to answer 11 them? 12 A. Yes. 13 Q. And it then became their 14 responsibility to make sure that the questions 15 were answered and that the answers were 16 implemented? 17 A. Yes. 18 Q. And this is across the board 19 with all clinical trials, not just Fluoxetine 20 clinical trials? 21 A. Yes. 22 Q. Would there -- were there a 23 fair number of deficiencies at this site when you 24 did this audit? Page 130 1 MR. MYERS: When you say fair number, 2 fair number compared to what? 3 MS. ZETTLER: Compared to normal. 4 A. It seems like a lot of 5 deficiencies, but then when I look at the number 6 of patients enrolled, it may be no more than any 7 other clinical trial. 8 Q. Okay. How many patients were 9 enrolled? 10 A. There was I saw on here a 11 hundred and seventy-eight patients. 12 Q. Okay. Which exhibit are you 13 looking at? 14 A. That's Exhibit 8. 15 Q. Okay. And on the page after 16 that, I believe, looks like a memo or audit 17 comment? 18 A. Yes. 19 Q. And under number one, 20 approximately one-third of the patients audited 21 were found to have protocol violations? 22 A. Yes. 23 Q. Is that normal or typical? 24 A. Again, if we look at one-third Page 131 1 of twenty-five because twenty-five were audited, 2 and then -- it's hard to say. I would almost 3 have to look at a lot of reports and look at 4 statistics to say whether that is a lot or it's 5 an average. 6 Q. But in your experience as a 7 quality assurance rep, do you typically find that 8 a third of the patients that you audit when you 9 go to a site have protocol violations? 10 A. The ones I have done in the 11 last -- actually I did quite a few in the past 12 several months, and no, I didn't find that many. 13 Q. What percentage of protocol 14 violations do you typically find in an audit? 15 A. I may find a couple. 16 Q. Less than ten percent? 17 A. It's hard for me to put a 18 percent on it but I would -- maybe less than ten 19 but it's hard to say. 20 Q. Then at this Exhibit 8, the 21 fourth page in, the audit comments we are talking 22 about. 23 A. Yes. 24 Q. It goes on to basically list Page 132 1 the different types of violations, right, the 2 first one is patients on blinded, the second one 3 is exclusion criteria. It's listed by patients 4 though, correct? 5 A. Yes. 6 Q. And then if you go to the 7 following page, which is Pz 2451 1128. 8 A. Yes. 9 Q. The next category, it says two 10 patients audited had telephone visits rather than 11 visits to the site. 12 A. Yes. 13 Q. Is that typical, a typical 14 error that you find? 15 A. No. 16 Q. How about number three on the 17 next page, there were several instances of 18 changes to individual items on the Ham-D. Do you 19 typically find changes on recording of testing 20 results? 21 A. No. 22 Q. Then it goes on to list some 23 other sections, like number four, dose selection 24 talks about number -- Page 133 1 MR. MYERS: Is the question whether 2 four talks about dose selection? 3 MS. ZETTLER: Right. 4 Q. Number five is missing, the 5 next page starts at number six at the top. 6 A. Yes. 7 Q. Efficacy data. So this is 8 basically -- are these general comments about the 9 audit, not patient specific? 10 A. Well, they -- can you ask me 11 that again? 12 Q. Towards the beginning of this 13 where it says audit comments, it looked like, and 14 under number one it says approximately one-third 15 of the patients audited were found to have 16 protocol violations and then it listed violations 17 per patient, right? 18 A. Right. 19 Q. And then the rest of these 20 starting with like two through nine seemed to 21 talk more generally about the study, the audit, 22 the deficiencies found, as opposed to a patient 23 by patient description of individual 24 deficiencies, right? Page 134 1 A. Yes. 2 Q. So this was -- now as far as 3 Exhibit 8 relates to Exhibit 9 and the actual 4 questions that were formulated -- 5 A. Yes. 6 Q. -- would Exhibit 8 be generated 7 first and then the questions listed in Exhibit 9 8 come from -- 9 A. Let me look through here and 10 make sure that that's correct. Yes, that's 11 correct. 12 Q. How about Exhibit 10, how does 13 that fit into this entire scenario? 14 A. Exhibit 10 are the very 15 specific observations we find and out of these 16 very specific ones, detailed ones, we may 17 formulate an audit comment. 18 Q. Okay. So actually Exhibit 10 19 comes first? 20 A. Yes. 21 Q. And then Exhibit 8, right? 22 A. Yes. 23 Q. And then Exhibit 9? 24 A. Yes. Page 135 1 Q. Is a table such as Exhibit 10 2 done as a result of every audit? 3 A. Yes. 4 Q. And in this case, if you look 5 at the second page of the exhibit, it's got the 6 columns listings at the top, says worksheet and 7 CTM, that's because this is a CTM trial? 8 A. Correct. 9 Q. If it was a CRF trial, it would 10 have CRF in any other columns or just CRF? 11 A. Instead of worksheet, it would 12 have case report form and instead of CTM -- no, 13 worksheet with maybe source document, or maybe it 14 would be patient -- I don't know, there's like 15 one less column though. So it's probably 16 worksheet goes to case report form and then the 17 CTM column is not there. 18 Q. What's on the left-hand side 19 under category, the second one down, it says H 20 and P, what does that stand for? 21 A. History and physical. 22 Q. How about SCID, S-C-I-D? 23 A. That is a -- one of those 24 tests, those written tests, but I don't know what Page 136 1 S-C-I-D stands for. 2 Q. So it's like -- 3 A. It's like a Ham-D or something 4 along that same nature. 5 Q. Okay. Go towards the back of 6 the exhibit, let's see if I can find the page 7 here. Starting about six pages back at Pz 2451 8 1170, it says patients were audited by Leslie 9 Chiplis. 10 A. Yes, I did a lot of work that 11 day, didn't I? 12 Q. Then this is really just a 13 listing of the patients that you audited? 14 A. Yes. 15 Q. Did you have a form that you 16 fill out that this would be generated from? 17 A. Yes, it's actually just a piece 18 of paper with those kind of columns. 19 Q. Like these that were reflected 20 in Exhibit 10? 21 A. No. I have to take that back. 22 At that time, I just used -- I just used like a 23 notebook or something and write it down. 24 Q. You would write down patient Page 137 1 number, visit number, and things like that? 2 A. Yes, right. 3 Q. On the first part of the 4 substantive, after the cover sheet where it says 5 patients blank audited by Leslie Chiplis, it's 6 1171, page 117l. 7 A. Yes. 8 Q. Second from the bottom, it says 9 four, visit four, MDDDA? 10 A. Uh-huh. 11 Q. What does that mean? 12 A. It's again another one of those 13 scales. I think it's like a -- it's just some 14 kind of code for one of those scales, and 15 probably some kind of a mental test of some kind. 16 Q. Is Vicky Thompson a quality 17 assurance rep? 18 A. No, she was in the medical 19 department. 20 Q. So, is she the CIR? 21 A. No, I think at the time of this 22 audit she was a CRA. 23 Q. Why would she be auditing the 24 site? Page 138 1 A. Because there were so many 2 patients in this study and we didn't have enough 3 people from our department so we kind of 4 recruited some other people from the medical 5 department to help us. 6 Q. Okay. To your knowledge, what 7 would typically happen with the CRFs at the site, 8 would they be sent back to Lilly at different 9 intervals or would they be sent out together? 10 MR. MYERS: Now you are talking about 11 paper CRFs? 12 MS. ZETTLER: Right, if they used a 13 paper CRF. 14 A. I think they're sent at 15 intervals. 16 Q. So, I guess the impression from 17 these documents, and if I'm wrong please 18 straighten me out, but that you guys went and 19 reviewed a number of different visits for each of 20 the patients, correct? 21 A. Correct. 22 Q. So does that mean that in this 23 instance the information from the various visits 24 were transferred to Lilly either by the CTM or Page 139 1 the hard copies and then after they were 2 transferred to Lilly, you guys would come out and 3 audit it? 4 A. Yes. 5 Q. Was that fairly typical that 6 you would audit sites after visits were 7 transferred to Lilly? 8 A. Yes. But I have to say that if 9 there's corrections, then it's changed in the CTM 10 and it's changed to the data base. That data 11 base would not be frozen, so even though we asked 12 them to make a change, it gets into the Lilly 13 computer correctly. 14 Q. That's assuming that the sites -- 15 that the visits are audited at some point, isn't 16 it? 17 A. Yes. 18 Q. It's also my understanding from 19 talking to other employees that what happened at 20 least on some of the studies is that the 21 information from the CRFs were transferred back 22 to Lilly, entered into the computer through data 23 processing, checked by CRAs and once validated, 24 the data base was locked so that people at the Page 140 1 sites couldn't get back in or somebody else 2 couldn't get back in to change things without 3 somebody knowing, right? 4 A. Yes, that does happen 5 eventually. 6 Q. To your knowledge, is that done 7 on an interval basis? Like in other words say 8 all the visit one records from the study come in 9 and they're validated and looked at and 10 everything else, is the data base then left or is 11 that done at the end when all the visits are 12 brought in? 13 A. The data base is locked after 14 all the information is entered and they have 15 verified that their entry is correct and it 16 usually happens shortly before they write the 17 final report -- 18 Q. Okay. 19 A. -- which goes to the FDA. 20 Q. How do you assure then that 21 somebody doesn't go back in and change 22 information from visit one a year and a half 23 after visit one on a study such as this one 24 that's a long term study? Page 141 1 MR. MYERS: When you say somebody, do 2 you mean somebody at Lilly or -- 3 MS. ZETTLER: Yes, somebody at Lilly, 4 somebody at the site, anybody who has access to 5 the information, to the data base. 6 MR. MYERS: Well, I object to the form 7 only to the extent that I think she said that if 8 it was a CTM, there wouldn't be any. If it's a 9 CTM, there's a computer. 10 MS. ZETTLER: Right. Right now I'm 11 talking about the computer data base itself, not 12 the hard copy forms or whatever. 13 Q. My question is -- maybe it's 14 just my question but what I want to know is, 15 given the scenario that we talked about as to 16 what happens with say visit one, and I'll use 17 visit one again, say there's twenty people in the 18 trial and all the visit one information for all 19 twenty people is transferred back to Lilly and 20 goes into the process where it's entered into the 21 computer and checked by the CRAs and validated 22 and everything else, right? 23 A. Uh-huh. 24 Q. At some point it's transferred Page 142 1 into the data base, right? 2 A. Right. 3 Q. And if I'm wrong, tell me, but 4 I believe it's your testimony that that data base 5 isn't locked until the end of the study when all 6 the information is in and everything's been 7 cleaned, right? 8 A. Yes. 9 Q. How do you prevent, in that 10 situation, somebody going into the data base and 11 changing visit one information that's been 12 entered? 13 A. There's only a limited number 14 of people who even have access to get into the 15 data base once it gets into Lilly, and even at 16 the CTM at the site I couldn't go in there 17 without a code or something to go in and then 18 when there are changes, those changes are tracked 19 by the computer so it would pop up that so and so 20 with a certain code changed something. 21 Q. So if somebody went into visit 22 one for patient number twenty and made a change, 23 the computer would alert somebody else that 24 that's what happened? Page 143 1 A. Right. There's what they call 2 change control. 3 Q. Okay. What's change control? 4 A. Change control is kind of a 5 concept that you can't really go -- it has to do 6 more with computers than anything. Anyway at 7 this state that if you change something to 8 information in a computer, the computer makes 9 note of that and if anybody else goes into the 10 computer they'll find that such and such a person 11 went in and changed it and unless you have a 12 code, you can't even get in to change it, and 13 then even sometimes on some systems, you still 14 can't change it, it's very controlled computer 15 environment. 16 Q. What types of people would have 17 access to go in to make a change? 18 MR. MYERS: Into the clinical trial 19 data base? 20 MS. ZETTLER: Right. 21 A. I don't know. 22 Q. Would somebody such as yourself 23 have the ability to go in? 24 A. No, no, I couldn't, it's very Page 144 1 limited. 2 Q. What about the clinical 3 research physicians? 4 A. You know, I don't think so. 5 MR. MYERS: I was going to ask you a 6 question, but that's all right. When you say 7 clinical research physician -- 8 MS. ZETTLER: At Lilly. 9 MR. MYERS: Yes. But for that -- a 10 specific study or just as a general proposition? 11 MS. ZETTLER: As a general proposition. 12 MR. MYERS: Did all the clinical 13 research physicians have access or change access, 14 whatever you want to call it, do you know? 15 THE WITNESS: I'm sorry, I was sitting 16 here thinking of something. 17 Q. Do you know as a general rule 18 if clinical research physicians would have a 19 change access in a code to be able to change the 20 data in the data base? 21 A. I have to ask, when you say 22 clinical research physicians, are you talking 23 about Lilly people or investigators? 24 Q. Right, Lilly people. Page 145 1 A. You know, I don't think they 2 do, I don't think they have access to those 3 computers. 4 Q. What about the monitors, the 5 clinical -- not the clinical investigators, the 6 people off site, what about the clinical monitors 7 at Lilly, like the person who has control over 8 any given study, study A, study B, would they 9 have access to the data for that particular 10 clinical trial? 11 MR. MYERS: When you say monitor, are 12 you talking about a CRA? 13 MS. ZETTLER: No. 14 Q. Don't the clinical research 15 physicians in some capacity act as a monitor? In 16 other words, they say, like for instance -- as an 17 example, Doctor Beasley would be the clinical 18 monitor on HCEX? 19 MR. MYERS: The specific physician to 20 the specific study? 21 MS. ZETTLER: Right. 22 Q. In that case would Doctor 23 Beasley have access, to your knowledge, to that, 24 to the data base? Page 146 1 A. Not to my knowledge. 2 Q. How about somebody in systems, 3 one of the systems analysts? 4 A. I don't know. 5 Q. What if -- what happens when 6 you go out and do your audit and you find out if 7 there's a problem with visit number one? 8 A. Uh-huh. 9 Q. How do you go about making a 10 change in the data base? 11 A. Okay. We wouldn't make a 12 change to the data base. 13 Q. How would you set that process 14 in motion? 15 A. We would do just what we did 16 here, we would ask the manager or somebody in the 17 medical department to start the process to get 18 the data changed at the site and then it would -- 19 if it's a paper case report form, they make a 20 copy of that and send it in, or if it's a 21 computer, then I think there's one person at the 22 site who would have the ability to change that. 23 But it has to be approved because the system 24 won't let them just change things without Page 147 1 approval. 2 Q. I'm going to ask her to read 3 that back because I spaced out. 4 (THE COURT REPORTER READ BACK THE 5 REQUESTED TESTIMONY.) 6 Q. Okay. So if you found an 7 error, you would talk to say, for instance, Mike 8 Harrill, Mike Harrill would call somebody at the 9 site and say we found an error with the listing 10 of patient twenty-three's blood pressure for 11 instance, right? 12 A. Right. 13 Q. And then they would call and 14 correct it on the CRF, if they 15 used a CRF, send a corrected copy back to Lilly? 16 A. Yes. 17 Q. And how would the information 18 be changed in the computer? 19 A. I think the CRA takes care of 20 that part of the process and the medical -- and 21 one other step I forgot in there, if I called 22 Mike Harrill and said so and so's blood pressure 23 said one twenty and the medical records said one 24 twenty-two, then I would ask that person at the Page 148 1 site to verify that my observation is correct. 2 So it could be and it has happened that I made a 3 wrong observation and then they would send me a 4 message back that, you know, I made a wrong 5 observation, and then it would stay as it was. 6 Q. Do you know how the CRA goes 7 about making the changes in the data base? 8 A. I don't think -- I'm not sure 9 that they directly do, I think they have people 10 working with them who that's their job. 11 Q. Do you know who those people 12 are? 13 A. I don't know if that's the CIR 14 or it's an acronym of some kind. 15 Q. Okay. And they would actually 16 go in and make the changes? 17 A. Could be in the data entry and 18 I haven't been -- actually I've never worked in 19 medical so this area is -- I don't have first 20 hand knowledge of how they start doing those 21 things, it's hard for me to say absolutely sure. 22 Q. Would then a copy of the 23 corrected CRF be sent back to the investigation 24 sites? Page 149 1 A. Yes. 2 Q. Why does it go back and forth 3 like that? 4 A. Because we want the site to 5 have a copy of the case -- the same case report 6 form that we do, say if there's been a change on 7 a page of a case report form and the site has a 8 carbon copy, we want our final copy and their 9 final copy to match. 10 Q. So whatever printed out as a 11 result of a change in the computer is sent back 12 to the site? 13 A. Yes, and it should be the same. 14 It should be -- what's in the data base, what's 15 in our case report form at Lilly and what's on 16 the case report form at the site should be the 17 same. 18 Q. So they sent back, if they're 19 using a CRF, a written change, it goes through 20 the process, it's printed out after the change is 21 made in the computer and the computer copy is 22 sent back computerized or computer generated 23 copy? 24 A. I don't know -- it's not a Page 150 1 computer generated -- I'm sorry. It would be 2 just say this is a page and it has blood 3 pressure, it was the wrong one, they would mark 4 it out and initial and date it and make a 5 photostatic copy of it and send it back to the 6 site. 7 Q. Now I'm confused. Assuming 8 it's the CRF, the hard copy paper CRF and you 9 find -- you're looking at the source information, 10 you're comparing it to the CRF, you see that 11 there's a problem with the person's blood 12 pressure -- 13 A. Right. 14 Q. You bring it to their attention 15 back at Lilly, they call the site and see if 16 that's right and they make the correction -- 17 A. Yes. 18 Q. And they send you from the site 19 a corrected copy of the page from the CRF? 20 A. They probably would make a 21 copy, a photostatic copy of their correction and 22 send it to us. 23 Q. So they may actually physically 24 on the CRF form scratch it out, change it, Page 151 1 initial it and date it? 2 A. Send it back, right. 3 Q. And then what is it that you 4 sent back to them? 5 A. In that situation, I'll have to 6 recant what I said earlier, we probably don't 7 send anything back. But if we would find 8 something that needs to be corrected in house, we 9 would correct it and then mail it back, so it's 10 kind of a back and forth mailing, just the end 11 result should be that their final case report 12 form page and ours should be identical. 13 Q. So when it's something that you 14 find in house, for instance a CRA looks and sees 15 that there's a problem with the CRF -- 16 A. Right. 17 Q. -- they make the change to that 18 page and it's sent back to the sites? 19 A. Yes. 20 Q. So it's not a matter of a CRF 21 page going around and around? 22 A. No. 23 Q. Now we're going to make it more 24 complicated. How does this all work with the Page 152 1 CTM? 2 MR. MYERS: Assuming the same blood 3 pressure problem? 4 MS. ZETTLER: Sure. 5 A. Make it a very simple problem, 6 I don't know. 7 Q. Okay. Would it be -- is it 8 possible to transfer the computerized, the CTM 9 CRFs back and forth or is that something that you 10 would have to send the worksheet, change it on 11 the worksheet? 12 A. They don't really change the 13 worksheet, they would change it in the computer 14 and then you don't have to send things back and 15 forth because the computer will just print a 16 copy. 17 Q. Okay. 18 A. But what is different is the 19 internal workings of the computer with the change 20 control where it maps and names people who change 21 things and there's authorizations to change 22 things. 23 Q. So if you went in and wanted to 24 make a change at the site, you would have to be Page 153 1 authorized? 2 A. Yes. 3 Q. And the computer would know if 4 you were authorized? 5 A. Yes. 6 Q. Could it give you a list of 7 people who were authorized? 8 A. I don't know. 9 Q. But you would know -- if you, 10 Leslie Chiplis, wasn't sure if you could do that, 11 you could try to get in and the computer would 12 say, no, you can't get in because you're not 13 authorized? 14 A. It may let me go in to look at 15 data but you couldn't enter or change. 16 MS. ZETTLER: Can we take about a ten 17 minute break and let me look at my notes but I 18 think I'm pretty much done. 19 MR. MYERS: That would be fine. 20 (A SHORT RECESS WAS TAKEN.) 21 Q. Does the change authority vary 22 from study to study, to your knowledge? In other 23 words, would one person have authority to get 24 into the data base related to say ATX but another Page 154 1 person -- you know, but that person would not 2 have authority to get into another study? 3 A. I don't know, I don't know. 4 Q. Who decides who gets authority 5 to go in? 6 A. I don't know. 7 Q. Did you ever work on weekends? 8 A. At Lilly? 9 Q. Yes. 10 A. No. 11 Q. Does anybody work on weekends 12 at Lilly? 13 MR. MYERS: Anybody? 14 A. Yes, I know people work on 15 weekends. 16 Q. Okay. Is the building 17 generally open on weekends? 18 A. It's secured, you have to have 19 a security card to get in. 20 Q. But if you had that security 21 card you could get in? 22 A. Yes. 23 MS. ZETTLER: Okay. That's all I have. 24 (THE WITNESS WAS EXCUSED.) Page 155 1 COMMONWEALTH OF KENTUCKY) 2 : ss COUNTY OF JEFFERSON ) 3 4 I, MARY KATHLEEN NOLD, A NOTARY PUBLIC IN 5 AND FOR THE STATE OF KENTUCKY AT LARGE, DO HEREBY 6 CERTIFY THAT THE FOREGOING TESTIMONY OF 7 LESLIE M. CHIPLIS 8 WAS TAKEN BEFORE ME AT THE TIME AND PLACE AS 9 STATED IN THE CAPTION; THAT THE WITNESS WAS FIRST 10 DULY SWORN TO TELL THE TRUTH, THE WHOLE TRUTH, 11 AND NOTHING BUT THE TRUTH; THAT THE SAID 12 PROCEEDINGS WERE TAKEN DOWN BY ME IN STENOGRAPHIC 13 NOTES AND AFTERWARDS TRANSCRIBED UNDER MY 14 DIRECTION; THAT IT IS A TRUE, COMPLETE AND 15 CORRECT TRANSCRIPT OF THE SAID PROCEEDINGS SO 16 HAD; THAT THE APPEARANCES WERE AS STATED IN THE 17 CAPTION. 18 WITNESS MY SIGNATURE THIS THE 10TH DAY OF 19 OCTOBER, 1993. 20 MY COMMISSION EXPIRES MARCH 10, 1994. 21 22 23 _________________________ MARY KATHLEEN NOLD 24 COURT REPORTER AND NOTARY PUBLIC STATE OF KENTUCKY AT LARGE Page 156 1 2 3 E R R A T A S H E E T 4 5 COMMONWEALTH OF KENTUCKY ) : SS 6 COUNTY OF JEFFERSON ) 7 8 I, LESLIE M. CHIPLIS, THE UNDERSIGNED 9 DEPONENT, HAVE THIS DATE READ THE FOREGOING PAGES 10 OF MY DEPOSITION AND WITH THE CHANGES NOTED 11 BELOW, IF ANY, THESE PAGES CONSTITUTE A TRUE AND 12 ACCURATE TRANSCRIPTION OF MY DEPOSITION GIVEN ON 13 THE 24TH DAY OF SEPTEMBER, 1993 AT THE TIME AND 14 PLACE STATED THEREIN. 15 PAGE NO. LINE NO. CHANGE REASON Page 157 1 2 PAGE NO. LINE NO. CHANGE REASON 3 4 5 6 7 8 9 _____________________________ 10 LESLIE M. CHIPLIS 11 SWORN TO AND SUBSCRIBED BEFORE ME THIS 12 _____ DAY OF __________, 1993. 13 _____________________________ NOTARY PUBLIC, STATE OF 14 KENTUCKY AT LARGE Page 158 1 2 3 4 5 Page 159 1 (PLAINTIFFS' EXHIBIT NO. 1........................35 2 (PLAINTIFFS' EXHIBIT NO. 2........................55 3 (PLAINTIFF'S EXHIBIT NO. 3........................67 4 (PLAINTIFFS' EXHIBIT NO. 4........................72 5 (PLAINTIFFS' EXHIBIT NO. 5........................79 6 (PLAINTIFFS' EXHIBIT NO. 6.......................86 7 (PLAINTIFFS' EXHIBIT NO. 7........................87 8 (PLAINTIFFS' EXHIBITS NOS. 8, 9 and 9 10...............................................107 10 COMMONWEALTH.....................................156 11 E R..............................................157 12 13 14 15 16 17 18 Page 160